Trial intelligence / Profile preview

Domvanalimab + Zimberelimab in Advanced Rare Cancers

NCT06790706Phase 2

Key facts

Status: Active, not recruiting
Start: Oct 2025
Primary completion: Nov 2028
Countries: 1
Sponsor: Hospices Civils de Lyon
Modality: Monoclonal Antibodies

Drugs: domvanalimabzimberelimab
Conditions: peritoneal mesotheliomagestational trophoblastic tumor (GTN)thymic carcinoma (TC)anaplastic thyroid carcinoma (ATC)gastroenteropancreatic neuroendocrine tumor (GEP-NET)

Overview

Phase 2, open-label trial of domvanalimab and zimberelimab in peritoneal mesothelioma, gestational trophoblastic tumor (GTN), thymic carcinoma (TC) and 3 more (5 cohorts), sponsored by Hospices Civils de Lyon. Primary endpoints: Progression-Free Survival Rate at 24 weeks, Successful Human Chorionic Gonadotropin Normalization Rate at 24 weeks and 1 more. Started Oct 2025; status: active, not recruiting.

Design

5 arms

Study design: Non-randomizedOpen-labelSingle group

Cohort 1: Peritoneal mesotheliomas
Domvanalimab + Zimberelimab
Cohort 2: Gestational trophoblastic tumors
Domvanalimab + Zimberelimab
Cohort 3: Thymic carcinomas
Domvanalimab + Zimberelimab
Cohort 4: Anaplastic thyroid carcinomas
Domvanalimab + Zimberelimab
Cohort 5: GEP-NET & carcinoid tumors
Domvanalimab + Zimberelimab + FOLFOX-4

Who it enrols

Adult patients with advanced rare cancers (peritoneal mesothelioma, gestational trophoblastic tumor, thymic carcinoma, anaplastic thyroid carcinoma, or GEP-NET/carcinoid tumor) that progressed after at least one line of standard systemic treatment, with ECOG PS <= 1 and adequate organ function.

Endpoints

Primary

Progression-Free Survival Rate24 weeks
Successful Human Chorionic Gonadotropin Normalization Rate24 weeks
Overall Survival Rate24 weeks

Secondary

Overall Response Rate1 year
Progression-Free Survival
Resistance-Free Survival
Overall Survival
Duration of Response
Adverse Events17 months

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