Therapy Detail

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Therapy Name Olaparib + Pembrolizumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Olaparib Lynparza AZD2281|KU-0059436 PARP Inhibitor (Pan) 30 Lynparza (olaparib) binds to and inhibits PARP, resulting in inhibition of DNA repair and lethality in homologous-recombination deficient cells, and may be a sensitizing agent for chemotherapy and radiotherapy (PMID: 25028150, PMID: 24225019). Lynparza (olaparib) is FDA approved for treatment of ERBB2 (HER2)-negative breast cancer with deleterious or suspected deleterious germline BRCA mutations, ovarian cancer with deleterious or suspected deleterious germline BRCA mutations and received 3 or more prior therapies, metastatic pancreatic adenocarcinoma with deleterious or suspected deleterious germline BRCA mutations as a maintenance therapy, metastatic castration-resistant prostate cancer (mCRPC) with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations who progressed following enzalutamide or abiraterone, in combination with abiraterone in patients with mCRPC harboring deleterious or suspected deleterious BRCA mutations, as a maintenance therapy in recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and in epithelial ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline or somatic BRCA mutation, and in combination with Avastin (bevacizumab) as maintenance therapy in HDR defective epithelial ovarian, fallopian tube or primary peritoneal cancer as defined by deleterious or suspected deleterious BRCA mutation, and/or genomic instability (FDA.gov).
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 147 PD-L1/PD-1 antibody 117 Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-expressing NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemotherapy in NSCLC, with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, with axitinib or lenvatinib in RCC, with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemotherapy for patients with esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, and in combination with chemoradiation for cervical cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05203445 Phase II Olaparib + Pembrolizumab A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer Recruiting USA 0
NCT04548752 Phase II Olaparib + Pembrolizumab Olaparib Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations Recruiting USA 0
NCT02861573 Phase I Dexamethasone + Docetaxel + Pembrolizumab + Prednisone Olaparib + Pembrolizumab Enzalutamide + Pembrolizumab Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365) Recruiting USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 10
NCT05623319 Phase II Cisplatin + Etoposide + Pembrolizumab Olaparib + Pembrolizumab Carboplatin + Etoposide + Pembrolizumab Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC) (THOR) Recruiting ITA 0
NCT04380636 Phase III Carboplatin Pemetrexed Disodium Pembrolizumab Cisplatin Durvalumab Etoposide Olaparib + Pembrolizumab Paclitaxel Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN 19
NCT04753879 Phase II Olaparib + Pembrolizumab Capecitabine + Cisplatin + Gemcitabine + Irinotecan + Nab-paclitaxel Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer. Recruiting USA 0
NCT04643379 Phase II Carboplatin + Olaparib + Pembrolizumab Olaparib + Pembrolizumab Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma Active, not recruiting USA 0
NCT04624204 Phase III Pembrolizumab Cisplatin + Etoposide Cisplatin + Etoposide + Pembrolizumab Carboplatin + Etoposide Olaparib + Pembrolizumab Carboplatin + Etoposide + Pembrolizumab Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013) Recruiting USA | ITA | GBR | FRA | ESP | CAN | BEL | AUS 17
NCT05201612 Phase II Olaparib + Pembrolizumab Pembrolizumab and Olaparib in Homologous-recombination Deficient (HRD) Advanced Colorectal Cancer (CRC). (PEMBROLA) Recruiting ESP 0
NCT05156268 Phase II Olaparib + Pembrolizumab A Study of Pembrolizumab and Olaparib in People With Endometrial Cancer or Endometrial Carcinosarcoma Recruiting USA 0
NCT03976323 Phase III Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Olaparib + Pembrolizumab Cisplatin + Pembrolizumab + Pemetrexed Disodium Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006) Active, not recruiting USA | NZL | GBR | FRA | ESP | DEU | CAN | AUT | AUS 11
NCT04825990 Phase II Olaparib + Pembrolizumab Pembrolizumab and Olaparib in Recurrent/Metastatic, Platinum Resistant Nasopharyngeal Cancer (POINT) Recruiting ITA 0
NCT03834519 Phase III Abiraterone + Prednisone Enzalutamide Olaparib + Pembrolizumab Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) (KEYLYNK-010) Completed USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 9
NCT05568550 Phase II Pembrolizumab Olaparib + Pembrolizumab Pembro With Radiation With or Without Olaparib Recruiting USA 0
NCT04483544 Phase II Olaparib + Pembrolizumab Pembrolizumab and Olaparib in Cervical Cancer Patients Active, not recruiting USA 0
NCT05524935 Phase II Olaparib + Pembrolizumab Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma Recruiting USA 0
NCT04683679 Phase II Olaparib + Pembrolizumab Pembrolizumab A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer Recruiting USA 0
NCT05379972 Phase II Olaparib + Pembrolizumab Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers Recruiting USA 0
NCT04666740 Phase II Olaparib + Pembrolizumab A Study of Pembrolizumab and Olaparib for People With Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy Recruiting USA 0
NCT03976362 Phase III Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Nab-paclitaxel + Pembrolizumab Olaparib + Pembrolizumab A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008) Active, not recruiting USA | NZL | GBR | FRA | ESP | DEU | CAN | AUT | AUS 11
NCT03025035 Phase II Olaparib + Pembrolizumab Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer Recruiting USA 0
NCT05268510 Phase II Olaparib + Pembrolizumab Capecitabine + Oxaliplatin + Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Chemotherapy and Pembrolizumab, Followed by Pembrolizumab and Olaparib as Firstline Therapy in Her-2 Negative Gastric/GEJ Adenocarcinoma Active, not recruiting DEU 0
NCT04633902 Phase II Olaparib + Pembrolizumab Phase II Study of Olaparib and Pembrolizumab in Advanced Melanoma With Homologous Recombination (HR) Mutation Recruiting USA 0
NCT05033756 Phase II Olaparib + Pembrolizumab Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation or a Homologous Recombination Deficiency (COMPRENDO (COMPRENDO) Recruiting DEU 0
NCT04123366 Phase II Olaparib + Pembrolizumab Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | AUS 16
NCT04306367 Phase II Olaparib + Pembrolizumab Study of Pembrolizumab and Olaparib in Bile Duct Cancer Active, not recruiting USA 0
NCT06116578 Phase II Pembrolizumab Olaparib + Pembrolizumab Study Evaluating Pembrolizumab +/- Olaparib in TLS Positive Selected Resectable STS Followed by Adjuvant Pembrolizumab (NeoSarc) Not yet recruiting FRA 0


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