Trial results for the combination of nivolumab and etigilimab in participants with locally advanced or metastatic solid tumors were posted on ClinicalTrials.gov on 2025-03-17. The study, NCT04761198, reported an objective response rate (ORR) of 37.5% in patients with cervical carcinoma. This Phase 1b/2 study evaluated the efficacy and safety of the combination therapy across various tumor types.
Background
The study investigated etigilimab in combination with nivolumab for the treatment of locally advanced or metastatic solid tumors. Nivolumab is an established immunotherapy. The trial aimed to explore the potential of this combination in different advanced cancer settings.
Trial design
The study, NCT04761198, was an open-label, Phase 1b/2, multicenter study. It enrolled 76 participants with locally advanced or metastatic solid tumors, including specific cohorts for endometrial cancer, head and neck squamous cell carcinoma, cervical carcinoma, TMB-H + MSS solid tumors, rare tumors (uveal, de-differentiated liposarcoma, undifferentiated pleomorphic sarcoma, other sarcoma, germ cell tumors), and ovarian cancer. Participants received etigilimab every 2 weeks in combination with nivolumab (240 mg every 2 weeks). The study evaluated efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics.
Key results
Objective Response Rate (ORR) as assessed based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) varied across different tumor cohorts:
- In Cohort A (Endometrial Cancer CPI (PD-1/PD-L1) Naive), the ORR was 20.0% of participants.
- In Cohort B (Head and Neck Squamous Cell Carcinoma), the ORR was 0% of participants.
- In Cohort C (Cervical Carcinoma), the ORR was 37.5% of participants.
- In Cohort E (TMB-H + MSS Solid Tumors), the ORR was 0% of participants.
- In Cohort F (Rare Tumors - Uveal), the ORR was 25.0% of participants.
- In Cohort F (Rare Tumors - De-diff LPS), the ORR was 10.0% of participants.
- In Cohort F (Rare Tumors - UPS), the ORR was 16.7% of participants.
- In Cohort F (Rare Tumors - Other Sarcoma), the ORR was 0% of participants.
- In Cohort F (Rare Tumors - GCT), the ORR was 0% of participants.
- In Cohort G (Endometrial Cancer Post-CPI (PD-1/PD-L1) Treated), the ORR was 0% of participants.
- In Cohort H (Ovarian Cancer), the ORR was 10.0% of participants.
Regarding safety, in Cohort A (Endometrial Cancer CPI (PD-1/PD-L1) Naive), 11 Participants experienced Treatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions.
What this means
The results from this Phase 1b/2 study indicate that the combination of etigilimab and nivolumab showed varying objective response rates across different locally advanced or metastatic solid tumor types. Notably, patients with cervical carcinoma demonstrated the highest ORR at 37.5%, suggesting a potential benefit in this specific population. Other cohorts, such as head and neck squamous cell carcinoma and certain rare tumors, showed no objective responses. These findings provide initial insights into the activity and safety profile of this combination therapy, warranting further investigation in responsive tumor types.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04761198, titled "A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors," were posted on 2025-03-17 on clinicaltrials.gov.