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| Profile Name | MSH6 negative |
| Gene Variant Detail | |
| Relevant Treatment Approaches | PD-L1/PD-1 antibody Ipilimumab + Nivolumab |
| Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|---|
| MSH6 negative | Advanced Solid Tumor | predicted - sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | FDA approved - On Companion Diagnostic | Actionable | In a Phase I trial (GARNET) that supported FDA aproval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 41.6% (87/209), with a median duration of response not reached in patients with advanced mismatch repair deficient (dMMR) solid tumors, as indicated by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 2564-2564; NCT02715284). | detail... detail... detail... |
| MSH6 negative | gastroesophageal junction adenocarcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as second-line or subsequent therapy for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) gastroesophageal junction cancer that are unresectable, locally advanced, recurrent, or metastatic (NCCN.org). | detail... |
| MSH6 negative | colon cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as preferred primary or subsequent therapy for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | small intestine adenocarcinoma | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as a subsequent therapy for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | esophageal cancer | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | neuroendocrine tumor | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines for patients with locally advanced or metastatic well-differentiated, Grade 3 neuroendocrine tumors with mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | gallbladder cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as primary therapy for patients with unresectable or metastatic gallbladder cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC), or as subsequent-line therapy (NCCN.org). | detail... |
| MSH6 negative | colorectal cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | FDA approved | Actionable | In a Phase III (KEYNOTE-177) trial that supported FDA approval, Keytruda (pembrolizumab) treatment as first-line therapy significantly improved median progression-free survival (16.5 vs 8.2 mo, HR=0.60, p=0.0002) compared to chemotherapy in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) colorectal cancer (PMID: 33264544; NCT02563002). | 33264544 detail... |
| MSH6 negative | endometrial cancer | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | FDA approved - On Companion Diagnostic | Actionable | In a Phase I trial (GARNET) that supported FDA approval, Jemperli (dostarlimab-gxly) treatment demonstrated acceptable safety profile, and resulted in an objective response rate of 42.3% (30/71, 9 complete responses, 21 partial responses), with a median duration of response not reached in patients with recurrent or advanced endometrial cancer harboring mismatch repair deficiency (dMMR) as confirmed by a loss of MLH1, PMS2, MSH2, or MSH6 expression in an FDA-approved IHC test (PMID: 33001143; NCT02715284). | detail... 33001143 detail... |
| MSH6 negative | chordoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as systemic therapy for metastatic chordoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | Squamous Cell Carcinoma of Unknown Primary | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines for patients with squamous cell carcinoma of unknown primary with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | colorectal cancer | sensitive | PD-L1/PD-1 antibody | Nivolumab | FDA approved | Actionable | In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53, 1 complete response, 18 partial responses) and disease control for 12 weeks or more in 70% (37/53) of patients with microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) metastatic colorectal cancer (PMID: 28734759; NCT02060188). | 28734759 detail... detail... |
| MSH6 negative | colorectal cancer | sensitive | Ipilimumab + Nivolumab PD-L1/PD-1 antibody | Ipilimumab + Nivolumab | FDA approved | Actionable | In a Phase II (CheckMate 142) trial that supported FDA approval, Opdivo (nivolumab) and Yervoy (ipilimumab) combination treatment resulted in an objective response rate of 54.6% (65/119, 4 complete response, 61 partial response) and disease control over 12 weeks in 80% of patients with microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) metastatic colorectal cancer (PMID: 29355075; NCT02060188). | detail... detail... 29355075 |
| MSH6 negative | gallbladder cancer | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for gallbladder cancer patients with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | testicular germ cell cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as a third-line therapy for metastatic testicular germ cell cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | chondrosarcoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as systemic therapy for metastatic chondrosarcoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | penile cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as subsequent-line systemic therapy for metastatic/recurrent penile cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | rectum cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as a preferred primary therapy for advanced or metastatic rectum cancer patients with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | colon cancer | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | colon cancer | sensitive | PD-L1/PD-1 antibody | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as primary or subsequent therapy for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | endometrial carcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | FDA approved - On Companion Diagnostic | Actionable | In a Phase II trial (KEYNOTE-158) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 48% (38/79, 11 complete responses, 27 partial responses) in patients with advanced microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) endometrial carcinoma, with a median progression-free survival of 13.1 months (PMID: 34990208; NCT02628067). | detail... detail... 34990208 |
| MSH6 negative | endometrial carcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as a preferred second-line therapy for patients with recurrent or metastatic endometrial carcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | rectum cancer | sensitive | Ipilimumab + Nivolumab PD-L1/PD-1 antibody | Ipilimumab + Nivolumab | Guideline | Actionable | Opdivo (nivolumab) in combination with Yervoy (ipilimumab) is included in guidelines as a primary therapy for advanced or metastatic rectum cancer patients with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | ovarian cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as systemic therapy for patients with recurrent ovarian cancer with MSH6 deficiency (NCCN.org). | detail... |
| MSH6 negative | endometrial carcinoma | sensitive | PD-L1/PD-1 antibody | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a second-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent, metastatic, or high-risk endometrial carcinoma (NCCN.org). | detail... |
| MSH6 negative | pancreatic adenocarcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines for advanced or metastatic pancreatic adenocarcinoma patients with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | small intestine adenocarcinoma | sensitive | Ipilimumab + Nivolumab PD-L1/PD-1 antibody | Ipilimumab + Nivolumab | Guideline | Actionable | Opdivo (nivolumab) in combination with Yervoy (ipilimumab) is included in guidelines as an initial therapy for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | small intestine adenocarcinoma | sensitive | PD-L1/PD-1 antibody | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as an initial therapy for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | stomach cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as second-line or subsequent therapy for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) stomach cancer that are unresectable, locally advanced, recurrent, or metastatic (NCCN.org). | detail... |
| MSH6 negative | breast cancer | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines for patients with metastatic or unresectable breast cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) who have progressed on or following prior treatment (NCCN.org). | detail... |
| MSH6 negative | extrahepatic bile duct carcinoma | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for extrahepatic cholangiocarcinoma patients with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | extrahepatic bile duct carcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as primary therapy for patients with unresectable or metastatic extrahepatic cholangiocarcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC), or as subsequent-line therapy (NCCN.org). | detail... |
| MSH6 negative | intrahepatic cholangiocarcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as primary therapy for patients with unresectable or metastatic intrahepatic cholangiocarcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC), or as subsequent-line therapy (NCCN.org). | detail... |
| MSH6 negative | endometrial carcinoma | sensitive | PD-L1/PD-1 antibody | Avelumab | Guideline | Actionable | Bavencio (avelumab) is included in guidelines as a second-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent, metastatic, or high-risk endometrial carcinoma (NCCN.org). | detail... |
| MSH6 negative | hepatocellular carcinoma | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for patients with mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) hepatocellular carcinoma (NCCN.org). | detail... |
| MSH6 negative | Adenocarcinoma of Unknown Primary | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines for patients with adenocarcinoma of unknown primary with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | osteosarcoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as systemic therapy for metastatic osteosarcoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | prostate adenocarcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as a second-line therapy for patients with advanced or metastatic prostate adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | Advanced Solid Tumor | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | FDA approved | Actionable | In a combined analysis of 5 trials that supported FDA approval, Keytruda (pembrolizumab) therapy resulted in an objective response rate of 39.6% (59/149) in advanced solid tumor patients with high levels of microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (PMID: 30787022; NCT01876511, NCT02460198, NCT01848834, NCT02054806, NCT02628067). | detail... 30787022 |
| MSH6 negative | endometrial carcinoma | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as a second-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent, metastatic, or high-risk endometrial carcinoma (NCCN.org). | detail... |
| MSH6 negative | small intestine adenocarcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as an initial therapy for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | ovarian cancer | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as systemic therapy for patients with recurrent or advanced ovarian cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | rectum cancer | sensitive | PD-L1/PD-1 antibody | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a primary therapy for advanced or metastatic rectum cancer patients with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | Adenocarcinoma of Unknown Primary | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines for patients with adenocarcinoma of unknown primary with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | Ewing sarcoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as systemic therapy for metastatic Ewing sarcoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | colon cancer | sensitive | Ipilimumab + Nivolumab PD-L1/PD-1 antibody | Ipilimumab + Nivolumab | Guideline | Actionable | Opdivo (nivolumab), in combination with Yervoy (ipilimumab), is included in guidelines as primary or subsequent therapy for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | germ cell cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as recurrence therapy for patients with germ cell tumors with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | intrahepatic cholangiocarcinoma | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for intrahepatic cholangiocarcinoma patients with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | esophageal cancer | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as second-line or subsequent therapy for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) esophageal cancer that are unresectable, locally advanced, recurrent, or metastatic (NCCN.org). | detail... |
| MSH6 negative | ampulla of Vater adenocarcinoma | sensitive | Ipilimumab + Nivolumab PD-L1/PD-1 antibody | Ipilimumab + Nivolumab | Guideline | Actionable | Opdivo (nivolumab) and (ipilimumab) combination therapy is included in guidelines as first-line or subsequent therapy for metastatic ampullary adenocarcinoma patients with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | rectum cancer | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Phase II | Actionable | In a Phase II trial, neoadjuvant Jemperli (dostarlimab-gxly) treatment resulted in an objective response of 100% (12/12, all complete responses) in patients with stage II or III rectal cancer with deficient mismatch repair (dMMR) as defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC (PMID: 35660797; NCT04165772). | 35660797 |
| MSH6 negative | rectum cancer | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for patients with advanced or metastatic rectal cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | ampulla of Vater adenocarcinoma | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as subsequent therapy for metastatic ampullary adenocarcinoma patients with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | stomach cancer | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced or metastatic gastric cancer with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | ampulla of Vater adenocarcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as first-line or subsequent therapy for metastatic ampullary adenocarcinoma patients with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | gastroesophageal junction adenocarcinoma | sensitive | PD-L1/PD-1 antibody | Dostarlimab-gxly | Guideline | Actionable | Jemperli (dostarlimab-gxly) is included in guidelines as second-line or subsequent therapy for patients with unresectable locally advanced, recurrent, or metastatic gastroesophageal junction adenocarcinoma with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | vulva squamous cell carcinoma | sensitive | PD-L1/PD-1 antibody | Pembrolizumab | Guideline | Actionable | Keytruda (pembrolizumab) is included in guidelines as a second-line therapy for patients with MSI high or dMMR (often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) vulva squamous cell carcinoma (NCCN.org). | detail... |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05069935 | Phase I | Atezolizumab + FT538 Cetuximab + FT538 FT538 + Trastuzumab FT538 + Pembrolizumab FT538 + Nivolumab Avelumab + FT538 Cyclophosphamide + Fludarabine | FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors | Recruiting | USA | 0 |
| NCT04964375 | Phase I | ABSK043 | A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor | Recruiting | 1 | |
| NCT04393454 | Phase II | Sirolimus | Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy | Recruiting | USA | 0 |
| NCT05001516 | Phase Ib/II | LM-302 | Study of LaNova Medicines(LM)-302 in Patients With Advance Solid Tumors | Recruiting | USA | 0 |
| NCT04730544 | Phase II | Ipilimumab + Nivolumab | Efficacy and Safety of Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI Metastatic Colorectal Cancer (NIPISAFE) | Recruiting | FRA | 0 |
| NCT04282018 | Phase Ib/II | BGB-10188 + Zanubrutinib BGB-10188 + Tislelizumab BGB-10188 | Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab | Recruiting | 2 | |
| NCT05173987 | Phase III | Cisplatin + Docetaxel Carboplatin + Docetaxel Carboplatin + Paclitaxel Cisplatin + Paclitaxel Pembrolizumab | Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) | Recruiting | USA | ITA | ESP | CAN | 13 |
| NCT04976634 | Phase II | Belzutifan + Lenvatinib + Pembrolizumab | Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016) | Recruiting | USA | FRA | ESP | BEL | 5 |
| NCT05272709 | Phase Ib/II | TT-702 | TT-702 in Patients With Advanced Solid Tumours. (CURATE) | Recruiting | 1 | |
| NCT04963283 | Phase II | Cabozantinib + Nivolumab | A Phase II Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer | Recruiting | USA | 0 |
| NCT05310643 | Phase II | Ipilimumab + Nivolumab | Nivolumab and Ipilimumab in Patients With dMMR and/or MSI Metastatic Colorectal Cancer Resistant to Anti-PD1 Monotherapy (NIPIRESCUE) | Recruiting | FRA | 0 |
| NCT03212404 | Phase I | Cosibelimab | Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers | Recruiting | FRA | ESP | 7 |
| NCT04817826 | Phase II | Durvalumab + Tremelimumab | TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC. (INFINITY) | Recruiting | ITA | 0 |
| NCT05417386 | Phase I | Fluorouracil + Irinotecan + Leucovorin + NIS793 + Oxaliplatin Capecitabine + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin | FOLFIRINOX + NIS793 in Pancreatic Cancer | Not yet recruiting | USA | 0 |
| NCT05118724 | Phase II | Atezolizumab | Atezolizumab With/Without IMM-101 in Patients With MSI-h/MMR-D Stage III Colorectal Cancer Ineligible for Oxaliplatin (ANTONIO) | Recruiting | DEU | 0 |
| NCT05337735 | Phase II | XmAb20717 | A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers | Recruiting | USA | 0 |
| NCT05419817 | Phase II | Pembrolizumab + Sitravatinib | Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System | Not yet recruiting | USA | 0 |
| NCT05156268 | Phase II | Olaparib + Pembrolizumab | A Study of Pembrolizumab and Olaparib in People With Endometrial Cancer or Endometrial Carcinosarcoma | Recruiting | USA | 0 |
| NCT04450901 | Phase I | YBL-006 | Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors | Recruiting | 3 | |
| NCT04935359 | Phase III | Gemcitabine + Nab-paclitaxel + NIS793 Gemcitabine + Nab-paclitaxel | Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 15 |
| NCT04991948 | Phase I | Fluorouracil + Leucovorin + NKR-2 cells + Oxaliplatin + Pembrolizumab | Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer | Recruiting | USA | BEL | 0 |
| NCT04197219 | Phase II | Axitinib + Pembrolizumab | Pembrolizumab With Axitinib in Recurrent Endometrial Cancer | Withdrawn | 0 | |
| NCT05000294 | Phase Ib/II | Atezolizumab + Tivozanib | Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types | Suspended | USA | 0 |
| NCT03506997 | Phase II | Pembrolizumab | Trial of Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (PERSEUS1) | Recruiting | 1 | |
| NCT04729322 | Phase I | Fecal microbiota + Nivolumab Fecal microbiota + Pembrolizumab | Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders | Recruiting | USA | 0 |
| NCT05382741 | Phase II | Durvalumab + Regorafenib | Adjuvant Durvalumab Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial (VIVA) | Recruiting | ITA | 0 |
| NCT05005728 | Phase II | XmAb20717 Olaparib + XmAb20717 Cabazitaxel + Carboplatin + XmAb20717 | XmAb20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer | Recruiting | USA | 0 |
| NCT04729959 | Phase II | Atezolizumab + Tocilizumab | Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma | Suspended | USA | 0 |
| NCT03186326 | Phase II | Aflibercept + Fluorouracil + Irinotecan + Leucovorin Aflibercept + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Panitumumab Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin + Panitumumab Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Avelumab Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin | Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer (SAMCO) | Active, not recruiting | FRA | 0 |
| NCT04272034 | Phase I | INCB099318 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors | Recruiting | USA | BEL | 5 |
| NCT05032040 | Phase II | XmAb20717 | A Study of XmAb20717 in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies | Recruiting | USA | 0 |
| NCT04006262 | Phase II | Ipilimumab + Nivolumab | Peri-operative Association of Immunotherapy (Pre-operative Association of Nivolumab and Ipilimumab, Post-operative Nivolumab Alone) in Localized Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR) Oeso-gastric Adenocarcinoma (NEONIPIGA) | Recruiting | FRA | 0 |
| NCT03475953 | Phase Ib/II | Avelumab + Regorafenib | A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors (REGOMUNE) | Recruiting | FRA | 0 |
| NCT05178576 | Phase II | XOMA 052 | A Single Arm Phase II Study to Evaluate Treatment With Gevokizumab in Patients With Stage II/III Colon Cancer Who Are ctDNA-positive After Curative Surgery and Adjuvant Chemotherapy | Recruiting | USA | 0 |
| NCT04659382 | Phase II | Atezolizumab + Bevacizumab + Capecitabine + Oxaliplatin | Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients With Liver-dominant Metastatic Colorectal Cancer (SIRTCI) | Recruiting | FRA | 0 |
| NCT05077800 | Phase II | 9-ING-41 + Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Losartan + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin 9-ING-41 + Fluorouracil + Irinotecan + Leucovorin + Losartan + Oxaliplatin | FOLFIRINOX + 9-Ing-41 + Losartan In Pancreatic Cancer | Recruiting | USA | 0 |
| NCT05141721 | Phase II | Atezolizumab + GRT-C901 + GRT-R902 + Ipilimumab | A Study of a Personalized Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer | Recruiting | USA | 0 |
| NCT05308446 | Phase II | Cetuximab + Encorafenib Cetuximab + Encorafenib + Nivolumab | Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation | Recruiting | USA | 0 |
| NCT04262687 | Phase II | Bevacizumab + Capecitabine + Oxaliplatin + Pembrolizumab | Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate (POCHI) | Recruiting | FRA | 0 |
| NCT04906382 | Phase I | Carboplatin + Paclitaxel + Tislelizumab | Tislelizumab for the Treatment of Recurrent Mismatch Repair Deficient Endometrial Cancer | Suspended | USA | 0 |
| NCT04795661 | Phase II | Pembrolizumab | Immunotherapy in MSI/dMMR Tumors in Perioperative Setting. (IMHOTEP) | Recruiting | FRA | 0 |
| NCT05064059 | Phase III | Regorafenib + Trifluridine-tipiracil hydrochloride MK-4280A | A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | 15 |
| NCT05328908 | Phase III | Regorafenib + Trifluridine-tipiracil hydrochloride nivolumab and relatlimab-rmbw | A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer (RELATIVITY-123) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 14 |
| NCT05197322 | Phase II | Pembrolizumab | NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer (NEOPRISM-CRC) | Recruiting | 1 | |
| NCT05263492 | Phase II | Lenvatinib + Pembrolizumab | Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer | Recruiting | USA | 0 |
| NCT05099549 | Phase Ib/II | AFM24 + SNK01 | Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers | Recruiting | USA | 0 |
| NCT04019964 | Phase II | Nivolumab | Nivolumab in Biochemically Recurrent dMMR Prostate Cancer | Recruiting | USA | 0 |
| NCT05217446 | Phase II | Pembrolizumab Cetuximab + Encorafenib + Pembrolizumab | A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer (SEAMARK) | Recruiting | USA | ITA | ESP | 3 |
| NCT04166721 | Phase Ib/II | Atezolizumab + DKN-01 | WaKING: Wnt and checKpoint INhibition in Gastric Cancer | Recruiting | 1 | |
| NCT04895722 | Phase II | MK-4280A MK-7684A MK-1308A MK-4830 + Pembrolizumab Pembrolizumab | Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 5 |
| NCT03724071 | Phase Ib/II | Flucytosine + TG6002 | Study of TG6002 (VV TK-RR-FCU1) in Combination With 5-FC in Patients With Advanced Gastro-intestinal Tumors. | Recruiting | FRA | ESP | BEL | 0 |
| NCT05200559 | Phase Ib/II | E7777 + Pembrolizumab | T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors | Not yet recruiting | USA | 0 |
| NCT02912572 | Phase II | Avelumab + Talazoparib Avelumab Avelumab + Axitinib | Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer | Recruiting | USA | 0 |
| NCT03851614 | Phase II | Cediranib + Durvalumab Durvalumab + Olaparib | Basket Combination Study of Inhibitors of DNA Damage Response, Angiogenesis and Programmed Death Ligand 1 in Patients With Advanced Solid Tumors (DAPPER) | Active, not recruiting | CAN | 0 |
| NCT05205330 | Phase Ib/II | Balstilimab + CR6086 | A Phase Ib/IIa Study of CR6086 in Combination With Balstilimab in pMMR-MSS Metastatic Colorectal Cancer Patients | Recruiting | ITA | 0 |
| NCT05425940 | Phase III | Atezolizumab + XL092 Regorafenib | Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer (STELLAR-303) | Recruiting | USA | 0 |
| NCT04952753 | Phase II | Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin + NIS793 Bevacizumab + Fluorouracil + Leucovorin + NIS793 + Oxaliplatin | Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC (daNIS-3) | Recruiting | USA | FRA | ESP | DEU | 7 |
| NCT04837196 | Phase Ib/II | ASP7517 + Pembrolizumab ASP7517 | Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen | Recruiting | USA | 0 |
| NCT05330429 | Phase II | Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Hu5F9-G4 + Irinotecan + Leucovorin | Study of Magrolimab Given Together With FOLFIRI/BEV in Participants With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC) | Recruiting | USA | 1 |
| NCT04984733 | Phase II | Nivolumab + Temozolomide | Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer (ELEVATE) | Recruiting | 1 | |
| NCT02675946 | Phase I | CGX1321 CGX1321 + Pembrolizumab Cetuximab + CGX1321 + Encorafenib | CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596) | Recruiting | USA | 1 |
| NCT04751370 | Phase II | Ipilimumab + Nivolumab | Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer | Recruiting | USA | 0 |
| NCT05112601 | Phase II | Ipilimumab + Nivolumab Nivolumab | Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma | Recruiting | USA | 0 |
| NCT04551521 | Phase II | Atezolizumab Atezolizumab + Ipatasertib Atezolizumab + Pertuzumab + Trastuzumab Atezolizumab + Cobimetinib Alectinib Atezolizumab + Cobimetinib + Vemurafenib | CRAFT: The NCT-PMO-1602 Phase II Trial | Recruiting | DEU | 0 |
| NCT04705818 | Phase II | Durvalumab + Tazemetostat | Combining Epigenetic And Immune Therapy to Beat Cancer. (CAIRE) | Recruiting | FRA | 0 |
| NCT04800627 | Phase Ib/II | MLN4924 + Pembrolizumab | Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor | Active, not recruiting | USA | 0 |
| NCT03803553 | Phase III | Binimetinib + Cetuximab + Encorafenib Nivolumab Fluorouracil + Irinotecan + Leucovorin | Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer | Recruiting | USA | 0 |
| NCT03871959 | Phase I | Pembrolizumab + Xevinapant | Pembrolizumab In Combination With Debio 1143 In Pancreatic and Colorectal Advanced/Metastatic Adenocarcinoma (CATRIPCA) | Active, not recruiting | FRA | 0 |
| NCT05167409 | Phase II | Cetuximab + Evorpacept + Pembrolizumab | A Study of ALX148 With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer | Recruiting | USA | 0 |
| NCT04854434 | Phase II | Trifluridine-tipiracil hydrochloride Pembrolizumab + Selinexor Selinexor | A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations | Active, not recruiting | USA | 0 |