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Table 3 Ongoing and completed clinical trials exploring the efficacy of combination DNA targeting and immunotherapy agents

From: The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy

Clinical trial ID Cancer type DDR-targeted inhibitor ICI Targets Phase Clinical endpoint Status Refs
NCT04334941 SCLC Talazoparib Atezolizumab PARP+PD-L1 Phase 2 PFS, OS Recruiting [81]
NCT04068831 Renal Cell Carcinoma Talazoparib Avelumab PARP+PD-L1 Phase 2 ORR, PFS Recruiting [16]
NCT03964532 Advanced Breast Cancer Talazoparib Avelumab PARP+PD-L1 Phase 1 Phase 2 AEs, ORR, PFS, OS Recruiting [16]
NCT04678362 Urothelial Carcinoma Talazoparib Avelumab PARP+PD-L1 Phase 2 PFS, OS, DOR Recruiting [82]
NCT04173507 Lung Non-Squamous Non-Small Cell Carcinoma Talazoparib Avelumab PARP+PD-L1 Phase 2 ORR, DCR, Toxicity, PFS, OS, DOR, Active, not recruiting [16]
NCT03565991 BRCA or ATM Mutant Solid Tumors Talazoparib Avelumab PARP+PD-L1 Phase 2 OR, TTR, PFS, OS, DOR Active, not recruiting [83]
NCT02912572 Metastatic Endometrial Cancer Talazoparib Avelumab PARP+PD-L1 Phase 2 PFS, ORR, DOR, irPFS Recruiting [16]
NCT04052204 Advanced or Metastatic Solid Tumors Talazoparib Avelumab PARP+PD-L1 Phase 1
Phase 2
DLT, DOR, TTR, PFS, OS Terminated [38]
NCT03330405 Solid Tumors Talazoparib Avelumab PARP+PD-L1 Phase 2 DLT, OR, TTR, PFS, OS, DOR Active, not recruiting [83]
NCT03637491 Solid tumors Talazoparib Avelumab PARP+PD-L1 Phase1   Phase 2 DLTs, OR, AEs Terminated
Has Results
[83]
NCT04187833 Melanoma Talazoparib Nivolumab PARP+PD-1 Phase 2 BOR, PFS, irOR, irPFS, OS, AEs Recruiting [75]
NCT04158336 Solid Tumors Talazoparib Pembrolizumab PARP+PD-1 Phase 1 Phase 2 Safety and Tolerability, MTD, RP2D Recruiting [75]
NCT03101280 Advanced Gynecologic Cancers and TNBC Rucaparib Atezolizumab PARP+PD-L1 Phase 1 DLTs, OS, DOR, PFS Completed [83]
NCT04276376 Solid Tumors Rucaparib Atezolizumab PARP+PD-L1 Phase 2 ORR Recruiting [75]
NCT03824704 Solid Tumors Rucaparib Nivolumab PARP+PD-1 Phase 2 ORR, PFS, DOR Terminated
Has Results
[84]
NCT04624178 Leiomyosarcoma Rucaparib Nivolumab PARP+PD-1 Phase 2 ORR, PFS Recruiting [85]
NCT03338790 mCRPC Rucaparib Nivolumab PARP+PD-1 Phase 2 ORR, RR-PSA, PFS Active, not recruiting
Has Results
[83]
NCT03639935 Biliary Tract Cancer Rucaparib Nivolumab PARP+PD-1 Phase 2 PFS, OS Recruiting [84]
NCT03572478 Prostate Cancer or Endometrial Cancer Rucaparib Nivolumab PARP+PD-1 Phase 1 Phase 2 DLTs Terminated
Has Results
[83]
NCT02873962 Relapsed Ovarian, Fallopian Tube or Peritoneal Cancer Rucaparib Nivolumab PARP+PD-1 Phase 2 ORR, Safety and Tolerability, PFS, DOR Recruiting [84]
NCT03958045 SCLC Rucaparib Nivolumab PARP+PD-1 Phase 2 PFS, DCR, OS, ORR Recruiting [16]
NCT03522246 Ovarian Cancer Rucaparib Nivolumab PARP+PD-1 Phase 3 PFS, OS, ORR, DOR, Safety and Tolerability Active, not recruiting [83]
NCT02935634 Advanced Gastric Cancer Rucaparib Nivolumab Ipilimumab PARP+PD-1 + CTLA-4 Phase 2 ORR, DOR, AEs Active, not recruiting [16]
NCT03869190 Urothelial Cancer Niraparib Atezolizumab PARP+PD-L1 Phase 1 Phase 2 ORR, pCR, PFS, OS Recruiting [16]
NCT04313504 Head and Neck Cancer Niraparib Dostarlimab PARP+PD-1 Phase 2 ORR, AEs, PFS, OS Recruiting [86]
NCT03955471 Ovarian Cancer Niraparib Dostarlimab PARP+PD-1 Phase 2 ORR, DOR, PFS, OS, DCR Terminated [87]
NCT04068753 Cervix Cancer Niraparib Dostarlimab PARP+PD-1 Phase 2 Toxicity, DOR, PFS, OS Recruiting [38]
NCT04544995 Neuroblastoma and Osteosarcoma Niraparib Dostarlimab PARP+PD-1 Phase 1 DLTs, PFS, ORR Recruiting [88]
NCT04673448 Pancreatic, Ovarian or Fallopian Tube Cancer Niraparib Dostarlimab PARP+PD-1 Phase 1 bOR, PFS, DOR, OS, DC, AEs Recruiting [89]
NCT04701307 Lung Small Cell Carcinoma and Neuroendocrine Tumor Niraparib Dostarlimab PARP+PD-1 Phase 2 PFS, ORR, DCR, OS Recruiting [90]
NCT04493060 Pancreatic Cancer Niraparib Dostarlimab PARP+PD-1 Phase 2 DCR, ORR, TTNT, OS Recruiting [89]
NCT05126342 Ovarian, Peritoneal or Fallopian Tube Cancer Niraparib Dostarlimab PARP+PD-1 Phase 2 ORR, PFS, DCR, OS, TFST Not yet recruiting [91]
NCT03016338 Endometrial Cancer Niraparib Dostarlimab PARP+PD-1 Phase 2 CBR, ORR, DOR, PFS Active, not recruiting [92]
NCT03307785 Advanced or Metastatic Solid Cancer Niraparib Dostarlimab PARP+PD-1 Phase 1 DLTs, ORR, DOR, DCR Active, not recruiting
Has Results
[83]
NCT04584255 Breast Cancer Niraparib Dostarlimab PARP+PD-1 Phase 2 TILs, pCR Recruiting [93]
NCT04940637 Lung Cancer or Mesothelioma Niraparib Dostarlimab PARP+PD-1 Phase 2 PFS, ORR, DCR, DOR, OS Recruiting [94]
NCT03651206 Ovarian Cancer and Endometrial Cancer Niraparib Dostarlimab PARP+PD-1 Phase 2 Phase 3 RR, OS, PFS, TTST Recruiting [84]
NCT04779151 Solid Tumors Niraparib Dostarlimab PARP+PD-1 Phase 2 ORR Not yet recruiting [96]
NCT03602859 Ovarian cancer Niraparib Dostarlimab PARP+PD-1 Phase 3 PFS, OS Active, not recruiting [83]
NCT03308942 NSCLC Niraparib Dostarlimab Pembrolizumab PARP+PD-1 Phase 2 ORR, PFS, OS Completed
Has Results
[83]
NCT04508803 Breast Cancer Niraparib HX008(Pucotenlimab) PARP+PD-1 Phase 2 ORR, PFS, OS, CBR, DOR Recruiting [86]
NCT03404960 Pancreatic Cancer Niraparib Nivolumab Ipilimumab PARP+PD-1 + CTLA-4 Phase 1 Phase 2 PFS, Safety and Tolerability, DOR, ORR Active, not recruiting [51]
NCT04178460 Gastric Cancer, TNBC, Biliary Tract Carcinoma and Endometrial Carcinoma Niraparib MGD013(Tebotelimab) PARP+ PD-1 + LAG-3 Phase 1 Safety and Validity profiles Terminated [97]
NCT02657889 TNBC or Ovarian Cancer Niraparib Pembrolizumab PARP+PD-1 Phase 1 Phase 2 DLTs, ORR, Safety and Tolerability, DOR Completed
Has Results
[83]
NCT04475939 NSCLC Niraparib Pembrolizumab PARP+PD-1 Phase 3 PFS, OS, TTP Recruiting [98]
NCT04885413 Endometrial Cancer Niraparib Sintilimab PARP+PD-1 Phase 2 ORR, DOR, PFS, DCR Recruiting [99]
NCT05162872 Nasopharyngeal Carcinoma Niraparib Sintilimab PARP+PD-1 Phase 2 ORR, DOR, PFS, DCR, OS Recruiting [91]
NCT02734004 Advanced Ovarian, Breast, Lung, and Gastric Cancers Olaparib Durvalumab PARP+PD-L1 Phase1   Phase 2 DCR, ORR, Safety and Tolerability Active, not recruiting [83]
NCT03334617 NSCLC Olaparib Durvalumab PARP+PD-L1 Phase 2 ORR, DOR, PFS, DCR, OS Recruiting [83]
NCT02484404 Recurrent Ovarian, TNBC, Lung, Prostate, and Colon Cancers Olaparib Durvalumab PARP+PD-L1 Phase 1 Phase 2 ORR, RP2D, AEs Recruiting [30, 49, 80, 84]
NCT04644289 Epithelial Ovarian Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 Safety, Feasibility Recruiting [100]
NCT03923270 Small-cell Lung Cancer Olaparib Durvalumab PARP+PD-L1 Phase 1 AEs, PFS, OS Recruiting [51]
NCT03851614 MMR proficient Colorectal Cancer, Pancreatic Cancer, and Leiomyosarcoma Olaparib Durvalumab PARP+PD-L1 Phase 2 ORR, CBR, PFS Active, not recruiting [84]
NCT03534492 Bladder Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 pCRR, Toxicity Completed [101]
NCT03167619 TNBC Olaparib Durvalumab PARP+PD-L1 Phase 2 PFS, OS, ORR Active, not recruiting [83]
NCT05222971 Biliary Tract Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 PFS, OS, Toxicity Recruiting [91]
NCT03594396 Advanced or mTNBC Olaparib Durvalumab PARP+PD-L1 Phase 1 Phase 2 pCR, RR Active, not recruiting [75]
NCT03544125 TNBC Olaparib Durvalumab PARP+PD-L1 Phase 1 AEs, ORR, DOR, PFS, OS Completed [16]
NCT03801369 mTNBC Olaparib Durvalumab PARP+PD-L1 Phase 2 ORR, OS Recruiting [16]
NCT03737643 Ovarian cancer Olaparib Durvalumab PARP+PD-L1 Phase 3 PFS, pCR, ORR Recruiting [16]
NCT03459846 Bladder Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 PFS, OS, DOR, ORR Active, not recruiting [83]
NCT03991832 Solid Tumors Olaparib Durvalumab PARP+PD-L1 Phase 2 ORR, PFS, OS Recruiting [102]
NCT02882308 Head and Neck Squamous Cell Carcinoma Olaparib Durvalumab PARP+PD-L1 Phase 2 ORR, pCR Completed [84]
NCT03772561 Advanced Solid Tumors Olaparib Durvalumab PARP+PD-L1 Phase 1 ORR Recruiting [84]
NCT03775486 Lung Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 PFS, OS, DOR, ORR Active, not recruiting [16]
NCT05209529 TNBC Olaparib Durvalumab PARP+PD-L1 Phase 2 OS, pCR Not yet recruiting [91]
NCT04538378 Lung Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 ORR, PFS, Safety and Tolerability, OS Recruiting [103]
NCT04336943 Prostate Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 Undetectable PSA, AEs Recruiting [104]
NCT03951415 Endometrial Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 PFS, ORR, OS Active, not recruiting [44]
NCT04169841 Solid Tumors Olaparib Durvalumab, Tremelimumab PARP+PD-L1 + CTLA-4 Phase 2 PFS Recruiting [16]
NCT02953457 Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer with BRCA Mutation Olaparib Durvalumab Tremelimumab PARP+PD-L1 + CTLA-4 Phase 2 DLTs, PFS, OS Active, not recruiting [84]
NCT03699449 Recurrent Ovarian Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 ORR, OS, PFS Recruiting [16]
NCT04306367 Bile Duct Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 RR, DOR, PFS, OS, Safety and Tolerability Recruiting [105]
NCT03810105 Prostate Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 PSA detection Recruiting [16]
NCT02546661 Bladder Cancer Olaparib Durvalumab PARP+PD-L1 Phase 1 Safety and Tolerability, ORR, DCR, PFS, DOR, OS Active, not recruiting [83]
NCT04269200 Endometrial Cancer Olaparib Durvalumab PARP+PD-L1 Phase 3 PFS, OS, ORR, DOR, TFST Recruiting [16]
NCT03741426 Renal Cancer Olaparib Durvalumab PARP+PD-L1 Phase 2 Proof-of-Mechanism, AEs Recruiting [16]
NCT04641728 Cervical Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 ORR, DOR, DRR, PFS Active, not recruiting [106]
NCT04380636 NSCLC Olaparib Pembrolizumab PARP+PD-1 Phase 3 PFS, OS, ORR, DOR, AEs Recruiting [44]
NCT04483544 Cervical Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 irORR, PFS, TEAEs, DOR Recruiting [44]
NCT02861573 mCRPC Olaparib Pembrolizumab PARP+PD-1 Phase 1  Phase2 AEs, ORR, DCR, OS, DOR, PFS Recruiting [83]
NCT04191135 Advanced TNBC Olaparib Pembrolizumab PARP+PD-1 Phase 2 PFS, OS Active, not recruiting [93]
NCT04123366 Solid Tumors Olaparib Pembrolizumab PARP+PD-1 Phase 2 ORR, DOR, PFS, OS, AEs Recruiting [16]
NCT04548752 Pancreatic Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 PFS, OS, ORR, AEs Recruiting [89]
NCT03834519 Prostate Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 3 OS, rPFS Active, not recruiting [107]
NCT04666740 Metastatic Pancreatic Ductal Adenocarcinoma Olaparib Pembrolizumab PARP+PD-1 Phase 2 PFS, OS Recruiting [108]
NCT05033756 Breast Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 ORR, DOR, PFS, OS, Safety and Toxicity Not yet recruiting [91]
NCT03976362 Squamous NSCLC Olaparib Pembrolizumab PARP+PD-1 Phase 3 PFS, OS, AEs Active, not recruiting [51]
NCT04633902 Metastatic Melanoma Olaparib Pembrolizumab PARP+PD-1 Phase 2 ORR, PFS, OS, Safety and Toxicity Recruiting [90]
NCT05201612 Metastatic Colorectal Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 ORR, PFS, OS, DCR, DOR Not yet recruiting [91]
NCT05093231 Pancreatic Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 ORR, Safety and Toxicity, PFS, DOR, OS Not yet recruiting [109]
NCT03740165 Ovarian Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 3 PFS, OS Active, not recruiting [16]
NCT05203445 Breast Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 MRGB Recruiting [91]
NCT05156268 Endometrial Carcinosarcoma Olaparib Pembrolizumab PARP+PD-1 Phase 2 ORR Recruiting [91]
NCT03025035 Breast Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 ORR, PFS, OS, CBR, DOR Recruiting [93]
NCT04417192 Ovarian Cancer Olaparib Pembrolizumab PARP+PD-1 Phase 2 ORR, CRS, OS, PFS Recruiting [100]
NCT02485990 Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Olaparib Tremelimumab PARP+CTLA-4 Phase 1 AEs, MTD, PFS, OS, ORR, DCR, DOR Terminated [16]
NCT04034927 Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer Olaparib Tremelimumab PARP+CTLA-4 Phase 2 PFS, DLT, OS, AEs Active, not recruiting [16]
NCT02571725 BRCA mutant Ovarian Cancer Olaparib Tremelimumab PARP+CTLA-4 Phase 1
Phase 2
RP2D, ORR, PFS Active, not recruiting [75]
NCT02660034 Solid Tumors Pamiparib Tislelizumab PARP+PD-1 Phase 1 AEs, DLT, ORR, DOR, PFS, OS, DCR, CBR Completed Has Results [83]
NCT03061188 Solid tumors Veliparib Nivolumab PARP+PD-1 Phase 1 MTD, AEs, ORR, CBR, PFS Active, not recruiting
Has Results
[75]
NCT04216316 Advanced Squamous Cell NSCLC Berzosertib Pembrolizumab ATR + PD-1 Phase 1
Phase 2
RP2D, PFS, OS Recruiting [110]
NCT04266912 Solid Tumors Berzosertib Avelumab ATR + PD-L1 Phase 1
Phase 2
AEs, DLTs, MTD, CBR, RR, PFS, OS Recruiting [75]
NCT05061134 Melanoma Ceralasertib Durvalumab ATR + PD-L1 Phase 2 ORR, DOR, TTR, PFS Recruiting [111]
NCT03334617 NSCLC Ceralasertib Durvalumab ATR + PD-L1 Phase 2 ORR, DCR, DOR, PFS, OS Recruiting [75]
NCT04298008 Biliary Tract Cancer Ceralasertib Durvalumab ATR + PD-L1 Phase 2 DCR, ORR, PFS, OS, DOR Recruiting [112]
NCT03780608 Gastric Adenocarcinoma and Malignant Melanoma Ceralasertib Durvalumab ATR + PD-L1 Phase 2 ORR Active, not recruiting [16]
NCT03833440 NSCLC Ceralasertib Durvalumab ATR + PD-L1 Phase 2 DCR, ORR, PFS, OS, DOR Recruiting [16]
NCT02664935 NSCLC Ceralasertib Durvalumab ATR + PD-L1 Phase 2 OR, PFS, DCB Active, not recruiting [44]
NCT02264678 Solid Tumors Ceralasertib Durvalumab ATR + PD-L1 Phase 1
Phase 2
Safety and Tolerability, Cmax, Tmax Recruiting [75]
NCT04095273 Solid Tumors Elimusertib Pembrolizumab ATR + PD-1 Phase 1 TEAEs, DLTs, RP2D Recruiting [110]
NCT03495323 Advanced Solid Tumors Prexasertib LY3300054 CHK1 + PD-L1 Phase 1 Toxicity Completed [113]
NCT02546661 Bladder Cancer Adavosertib Durvalumab WEE1 + PD-L1 Phase 1 AEs, ORR, DCR, PFS, OS, DOR Active, not recruiting [114]
NCT02617277 Solid Tumors Adavosertib Durvalumab WEE1 + PD-L1 Phase 1 DLTs, TEAEs, ORR, PFS Active, not recruiting [51]
  1. AE Adverse event, bOR Best objective response, BOR Best overall response, CBR Clinical benefit rate (CBR = CR + PR + SD), Cmax Maximum observed plasma concentration, CRS Chemotherapy response score, DC Disease control, DCB Durable clinical benefit, DCR Disease control rate, DLT Dose limiting toxicity, DOR Duration of response, DRR Durable response rate, irOR Immune-related overall response, irORR Immune-related overall response rate, irPFS Immune-related progression free survival, mCRPC Metastatic castration-resistant prostate cancer, MMR Mismatch repair, MRGB MRI-guided biopsy, MTD Maximum tolerated dose, mTNBC Metastatic triple-negative breast cancer, NSCLC Non-small cell lung cancer, OR Objective response, ORR Overall response rate, OS Overall survival, pCR Pathologic complete response, pCRR Pathological complete response rate, PFS Progression-free survival, PSA Prostate-specific antigen, rPFS Radiographic progression-free survival, RP2D Recommended phase II dose, RR Response rate, RR-PSA Prostate-specific antigen response rate, SCLC Small cell lung cancer, TEAEs Treatment emergent adverse events, TFST Time to initiation of the first subsequent anticancer therapy, TILs Tumor-infiltrating lymphocytes, Tmax Time to observed Cmax, TNBC Triple-negative breast cancer, TTNT Time to next treatment, TTP Time to progression, TTR Time to tumor response, TTST Time to subsequent treatment