Table 3.
Ongoing early phase clinical trials of immunotherapy in gastrointestinal cancers.
| NCT Number | Line of Therapy | Drug Name | Trial Name | Trial Design | Standard Arm | PDL1 Status |
|---|---|---|---|---|---|---|
| Gastro-Esophageal Cancer | ||||||
| NCT 02954536 |
First | Pembrolizumab + Trastuzumab and chemotherapy | A Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2+ Esophagogastric Cancer | phase II | none | no |
| NCT 02639065 |
First | Durvalumab | Study of Durvalumab (MEDI4736) in Esophageal Cancer | open label phase II |
none | no |
| NCT 02559687 |
Third | Pembrolizumab | KEYNOTE-180 | phase II | none | no |
| NCT 02689284 |
First/ Second |
Pembrolizumab + Margetuximab | Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer | phase 1b/2 open label dose escalation study | none | no |
| NCT 02335411 |
First/ Second |
Pembrolizumabor Pembrolizumab + chemotherapy | KEYNOTE-059 | phase II | none | no |
| Pancreatic Cancer | ||||||
| NCT 2826486 |
Second | Motixafortide + Pembrolizumab | COMBAT/KEYNOTE-202 | randomized phase IIa | BL-8040 | no |
| NCT 3184870 |
Second | BMS-813160 + Nivolumab | A Phase 1b/2 Study of BMS-813160 in Combination with Chemo or Nivolumab in Patients with Advanced Solid Tumors | non-randomized phase I/II | none | no |
| NCT 3193190 |
Second | Atezolizumab + chemotherapy + Selicrelumab | Morpheus-Pancreatic Cancer | randomized phase Ib and II | chemotherapy (nab-paclitaxel and gemcitabine) | no |
| NCT 03849469 |
Second | XmAb22841 + Pembrolizumab | DUET-4 | nonrandomized phase I | none | no |
| NCT 03257761 |
Second | Guadecitabine, Durvalumab | A Phase Ib Study of Guadecitabine and Durvalumab in Patients with Advanced Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, GB cancer, and Cholangiocarcinoma | phase Ib | none | no |
| NCT 04361162 |
Second (MSI stable) | Nivolumab + Ipilimumab | Nivolumab anD Ipilimumab and Radiation Therapy in Metastatic, Microsatellite Stable Pancreatic Cancer | phase II | none | no |
| NCT 03816358 |
Second | Anetumab Ravtansine, Nivolumab, Ipilimumab | A Phase I Study of Anetumab Ravtansine in Combination with Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma | Non-randomized phase I/II | Anetumab ravtansine, nivolumab, gemcitabine | no |
| NCT 04161755 |
First | Atezolizumab | Phase 1 Clinical Trial of Personalized Neoantigen Tumor Vaccines and Programmed Death-Ligand 1 (PD-L1) Blockade in Patients with Surgically Resected Pancreatic Cancer | phase I | Chemotherapy (mFOLFIRINOX) | no |
| NCT 03563248 |
First | Losartan + Nivolumab | A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer | randomized phase II | chemotherapy (FOLFIRINOX) | no |
| Hepatocellular Cancer | ||||||
| NCT 04170556 |
Second | Regorafenib + Nivolumab | The GOING Study: Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma Progressing Under Sorafenib | phase II | none | no |
| NCT 03316872 |
Second | Pembrolizumab + Radiotherapy | Pembrolizumab and Stereotactic Radiotherapy Combined in Subjects With Advanced Hepatocellular Carcinoma | phase II | none | no |
| NCT 04152356 |
First | Sorafenib + anti-PDI | Study on Combined Immunotherapy and Targeted Therapy for Hepatocellular Carcinoma | phase II | none | no |
| NCT 02821754 |
First | Durvalumab + Tremelimumab with or without TACE/RFA/cryo | A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) | phase II | none | no |
| NCT 03841201 |
First | Nivolumab + Lenvatinib | IMMUNIB trial | open label phase II | none | no |
| NCT03753659 | First | Pembrolizumab + Ablation | IMMULAB - A Phase II Trial of Immunotherapy With Pembrolizumab in Combination With Local Ablation for Patients With Early Stage Hepatocellular Carcinoma (HCC) | phase II | none | no |
| Biliary Tract Cancer | ||||||
| NCT 02866383 |
Second | Nivolumab + radiotherapy or Nivolumab/ Ipilimumab + radiotherapy |
A Prospective Randomized, Open-label Phase 2 Study of Immune Checkpoint Inhibition, Nivolumab With or Without Ipilimumab in Combination With Radiation Therapy in Pretreated Patients With Metastatic Pancreatic Cancer or Biliary Tract Cancer. | randomized open label phase II | none | no |
| NCT 03110328 |
Second | Pembrolizumab | Phase II Study of Pembrolizumab in Metastatic Biliary Tract Cancer as Second-line Treatment After Failing to at Least One Cytotoxic Chemotherapy Regimen: Integration of Genomic Analysis to Identify Predictive Molecular Subtypes | phase II | none | no |
| NCT 02829918 |
Second | Nivolumab | A Phase II Investigator Sponsored Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers | phase II | none | no |
| NCT 03999658 |
Second | STI-3031, an anti-PD-L1 antibody | An Open-label, Multicenter, Global Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Malignancies | open label phase II | none | no |
| NCT 03250273 |
Second | Entinostat + Nivolumab | A Phase 2 Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma | Phase II | none | no |
| NCT 03473574 |
First | Durvalumab + Tremelimumab + chemotherapy | IMMUCHEC trial | randomized phase II | none | no |
| NCT 03796429 |
First | Toripalimib + chemotherapy | A Single-arm, Single-center, Prospective Clinical Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Treatment of Advanced Biliary Tract Cancer | phase II | none | no |
| NCT 03201458 |
First | Atezolizumab + Cobimetinib or Atezolizumab | A Randomized Phase 2 Study of Atezolizumab in Combination With Cobimetinib Versus Atezolizumab Monotherapy in Participants With Unresectable Cholangiocarcinoma | randomized phase II | none | no |
| NCT 03101566 |
First | Nivolumab + chemotherapy or Nivolumab + Ipilimumab | A Randomized Phase II Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer | randomized phase II | none | no |
| Colorectal Cancer | ||||||
| NCT 03228667 |
Second (MSI-H) | ALT-803 + anti-PD-1/PDL-1 antibody | QUILT-3.055 trial | phase IIb | none | no |
| NCT 02484404 |
Second | MEDI4736, anti-PDL-1 + Olaparib and/or Cediranib | Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced Colorectal Cancers | phase I/II | none | no |
| NCT 02754856 |
Second |
Tremelimumab + Durvalumab | Pilot Study Assessing the Safety and Tolerability of the Neoadjuvant Use of Tremelimumab (Anti-CTLA-4) Plus Durvalumab (MEDI4736) (Anti-PD-L1) in the Treatment of Resectable Colorectal Cancer Liver Metastases | phase II | none | no |
| NCT 02982694 |
Second (MSI-H) | Atezolizumab + Bevacizumab | A Phase II Open-label Study with the Anti-PD-L1 Atezolizumab Monoclonal Antibody in Combination With Bevacizumab in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and MSI-like Molecular Signature | open label phase II | none | no |
| NCT 04118933 |
Second (MSI-H) | JSOO1 Anti PDL-1 antibody |
An Exploratory Study for PD-1 Antibody JS001 in Participants With Microsatellite Instability-high (MSI-H) Advanced or Recurrent Colorectal Cancer | phase II | none | no |
| NCT 03206073 |
Second | Pexa-Vec + Durvalumab or Durvalumab + Tremelimumab | A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination with Immune Checkpoint Inhibition in Refractory Colorectal Cancer | phase I/II | none | no |
| NCT 03186326 |
Second (MSI-H) | Avelumab | Multicenter Randomized Phase II Study Comparing the Effectiveness and Tolerance of Avelumab Versus Standard 2nd Line Treatment Chemotherapy in Patients with Colorectal Metastatic Cancer with Microsatellite Instability | randomized phase II | Chemotherapy (FOLFOX/FOLFIRI +/- anti-VEGF) | no |
| NCT 03376659 |
Second | Durvalumab + CV301 + Chemotherapy | A Phase I/II Trial of the PD-L1 Inhibitor, Durvalumab Plus CV301 in Combination with Maintenance Chemotherapy for Patients with Metastatic Colorectal or Pancreatic Adenocarcinoma | phase I/II | none | no |
| NCT 03608046 |
Second (MSS) | Avelumab + Cetuximab/Irinotecan | AVETUXIRI Trial | Phase IIa | none | no |
| NCT 03642067 |
First (MSS) | Nivolumab + Relatimab | Phase 2 Study Evaluating Response and Biomarkers in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer Treated With Nivolumab in Combination With Relatlimab | open label phase II | none | no |
| NCT 02811497 |
First (MSS) | Azacitidine + Durvalumab | METADUR trial | open label phase II | none | no |
| NCT 03202758 |
First | Durvalumab + Tremelimumab + FOLOFOX | Phase Ib/II Trial Evaluating the Safety, Tolerability and Immunological Activity of Durvalumab (MEDI4736) (Anti-PD-L1) Plus Tremelimumab (Anti-CTLA-4) Combined with FOLFOX in Patients with Metastatic Colorectal Cancer | Phase Ib/II | none | no |
| Anal Cancer | ||||||
| NCT 02314169 |
Second | Nivolumab | A Multi-Institutional Phase 2 Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal | phase II | none | no |
| NCT 03519295 |
Second | Atezolizumab + chemotherapy | SCARCE trial | randomized phase II | chemotherapy (docetaxel, cisplatin, 5-FU) | no |
| NCT 03944252 |
second | Avelumab or Cetuximab + Avelumab | CARACAS trial | randomized phase II | none | no |
| NCT 04230759 |
first | Durvalumab | Radio-chemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma | randomized phase II | chemotherapy (5-FU + Mitomycin C) | no |
| NCT 04046133 |
first/ second |
Pembrolizumab + chemotherapy | Phase 1b/II Trial of Pembrolizumab Plus IMRT in Stage III/IV Carcinoma of Anus | phase Ib/II | none | no |
| NCT 03233711 |
first | Nivolumab | Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer | randomized phase II | clinical observation | no |