Clinical trial · Interventional
COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors.
A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.
NCT04570839CI-TRIAL-00078941completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1/2 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COM701 in combination with BMS-986207 and nivolumab. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dose Escalation Cohorts.
- description
- Up to 5 sequential dose escalation cohorts of COM701 in combination with fixed doses of BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks until a maximum tolerated dose or recommended dose for expansion is identified.
- interventionNames
- Drug: COM701 in combination with BMS-986207 and nivolumab.
- type
- EXPERIMENTAL
- label
- Cohort 1 Expansion Cohort A (ovarian cancer)
- description
- Single arm: subjects with platinum resistant/refractory epithelial ovarian cancer, primary peritoneal or fallopian tube cancer will be randomized to receive study treatment with COM701 in combination with BMS-986207 and nivolumab. The study drugs will be administered IV every 4 weeks.
- interventionNames
- Drug: COM701 in combination with BMS-986207 and nivolumab.
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or is not a candidate for the available standard therapy. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * During dose escalation - Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti- CTLA-4, OX-40, CD137, etc., are eligible. During cohort expansion: All subjects must have measurable disease as defined by RECIST v1.1. Expansion Cohorts: * Cohort 1 (subjects with advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma) * Subject must have platinum refractory/resistant ovarian cancer defined as refractoriness to platinum-containing regimen or disease recurrence \< 6 months after completion of a platinum-containing regimen * Cohort 2 (endometrial cancer cohort) * Subjects with locally advanced or metastatic microsatellite stable endometrial cancer with disease recurrence or progression during or after prior therapy that included platinum-based chemotherapy. * Subjects must have documented MSS status by an approved test e.g. genomic testing, IHC for mismatch repair proficient. * Subjects must have received no more than 2 prior systemic cytotoxic therapies; there are no limits to the number of prior endocrine or antiangiogenic regimens * Cohort 3 (basket cohort, excludes tumor types in cohorts 1 and 2) * Tumor types with high expression of PVRL2 (determined by central testing). * Cohort 4 (Head and Neck cancer) * Histologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, paranasal sinus, nasopharyngeal) * Cohort 4a - IO naïve. Eligible subjects can be systemic therapy naïve (frontline) or platinum failure. * Cohort 4b - IO failure. No limitations on the number of prior lines of systemic therapy. Key Exclusion Criteria: * Active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose of COM701. * Symptomatic interstitial lung disease or inflammatory pneumonitis. * History of immune-related events that lead to immunotherapy treatment discontinuation. * Untreated or symptomatic central nervous system (CNS) metastases. Key Exclusion Criteria For Dose Expansion Cohorts: * Cohort 1: Prior therapy with an anti-PD-1/PD-L1/2, COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody. * Cohort 2: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody. Subjects with MSI-H endometrial cancer are ineligible. * Cohort 3: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody are ineligible. * Cohort 4: Subjects who have received prior therapy with COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody. Subjects in cohort 4a must be IO-naïve.
References
Publications (0)
Data not yet available
No reference posted for this study.