Volrustomig

HealthScout AI summary: Untreated adults with advanced/metastatic clear cell RCC (KPS ≥70%) are randomized to volrustomig (a PD‑1/CTLA‑4 bispecific designed to preferentially inhibit CTLA‑4 on PD‑1+ T cells) plus casdatifan (oral HIF‑2α inhibitor), volrustomig alone, or standard nivolumab/ipilimumab. Key exclusions include symptomatic CNS disease and active autoimmune disorders; endpoints focus on PFS/OS versus nivo/ipi.

ClinicalTrials.gov ID: NCT07000149

HealthScout AI summary: This trial enrolls adults with metastatic, pMMR/MSS colorectal adenocarcinoma (no liver or CNS metastases, ECOG 0-1, no prior systemic therapy for metastatic disease) to evaluate the addition of volrustomig—a bispecific anti-PD-1/CTLA-4 antibody—to FOLFIRI and bevacizumab versus standard FOLFIRI plus bevacizumab. Volrustomig is designed to enhance immune response by targeting CTLA-4 selectively on PD-1+ T cells.

ClinicalTrials.gov ID: NCT06792695

HealthScout AI summary: This trial enrolls treatment-naïve patients with stage IV non-squamous NSCLC (ECOG 0–1, no EGFR or other driver mutations) and randomizes them to one of two volrustomig priming regimens (a novel PD-1/CTLA-4 bispecific antibody) in combination with carboplatin and pemetrexed. Patients with stable, asymptomatic brain metastases may also be eligible.

ClinicalTrials.gov ID: NCT06448754

HealthScout AI summary: Adults with advanced/metastatic solid tumors in three cohorts: recurrent/metastatic cervical cancer after 1–2 prior lines; recurrent/metastatic HNSCC (including PD-L1–positive, systemic-therapy–naive or platinum-refractory); and untreated R/M HNSCC receive volrustomig, a bispecific PD-1/CTLA-4 antibody, as monotherapy or combined with chemo (carboplatin/paclitaxel or 5-FU plus platinum). Excludes prior checkpoint inhibitor exposure and requires ECOG 0–1 and PD-L1 testing; endpoints include ORR and safety per RECIST 1.1.

ClinicalTrials.gov ID: NCT06535607

HealthScout AI summary: Adults with unresectable pleural mesothelioma (epithelioid or non-epithelioid), ECOG 0–1, are randomized to volrustomig (a bispecific PD-1/CTLA-4 antibody) plus carboplatin/pemetrexed versus investigator’s choice of platinum/pemetrexed (epithelioid) or nivolumab plus ipilimumab (either histology; standard for non-epithelioid). Key exclusions include significant autoimmune disease and uncontrolled infections; primary endpoint is overall survival.

ClinicalTrials.gov ID: NCT06097728

HealthScout AI summary: This trial enrolls adults with metastatic squamous or non-squamous NSCLC (PD-L1 <50%, no actionable driver mutations) and compares volrustomig—a bispecific PD-1/CTLA-4 antibody—plus platinum-based chemotherapy to pembrolizumab plus chemotherapy as first-line treatment. Key exclusions include EGFR, ALK, or ROS1 alterations and untreated symptomatic brain metastases.

ClinicalTrials.gov ID: NCT05984277

HealthScout AI summary: Adults with advanced hepatobiliary cancers: HCC cohorts receive volrustomig (PD-1/CTLA-4 bispecific) or rilvegostomig (PD-1/TIGIT bispecific) as monotherapy or combined with bevacizumab or lenvatinib, including a triple-immunotherapy/bevacizumab arm; BTC cohort (first-line) receives volrustomig or rilvegostomig with gemcitabine/cisplatin. Aims to assess response/PFS and safety of dual-checkpoint bispecifics, leveraging PD-1–anchored CTLA-4 or TIGIT blockade to enhance intratumoral T-cell activity.

ClinicalTrials.gov ID: NCT05775159

HealthScout AI summary: First-line, unresectable/metastatic gastric or GEJ adenocarcinoma (ECOG 0–1), predominantly HER2-negative; some substudies require Claudin18.2-positive tumors. Non-randomized cohorts test bispecific checkpoint antibodies—PD-1/CTLA-4 (volrustomig), PD-1/TIGIT (rilvegostomig), or PD-1/TIM-3 (sabestomig)—alone with FOLFOX/XELOX or combined with a Claudin18.2-targeted MMAE ADC (AZD0901, sonesitatug vedotin) plus fluoropyrimidine.

ClinicalTrials.gov ID: NCT05702229

HealthScout AI summary: Adults with advanced/metastatic solid tumors (endometrial, gastric, mCRPC, ovarian, colorectal, urothelial, biliary) receive datopotamab deruxtecan (anti‑TROP2 antibody–drug conjugate delivering a topoisomerase I inhibitor) as monotherapy or combined with agents such as capecitabine/5‑FU, bevacizumab ± platinum, prednisone (mCRPC), platinum in urothelial cancer, or bispecific PD‑1/CTLA‑4 (volrustomig) or PD‑1/TIGIT (rilvegostomig) immunotherapies. Key exclusions include active/untreated CNS disease, prior TROP2- or deruxtecan-based ADCs, significant ILD/pneumonitis history, and uncontrolled infections/comorbidities.

ClinicalTrials.gov ID: NCT05489211

HealthScout AI summary: This trial enrolls adults with previously untreated advanced or metastatic non-squamous NSCLC with HER2 overexpression (no EGFR/ALK alterations), testing trastuzumab deruxtecan (HER2-directed antibody-drug conjugate) in combination with investigational bispecific checkpoint inhibitors (volrustomig [PD-1/CTLA-4] or rilvegostomig [PD-1/TIGIT]), with or without platinum chemotherapy. Patients must have good performance status and no major comorbidities.

ClinicalTrials.gov ID: NCT04686305

HealthScout AI summary: Adults with unresectable/metastatic HER2-expressing gastric/GEJ/esophageal adenocarcinoma (HER2-positive or HER2-low) receive trastuzumab deruxtecan (anti‑HER2 antibody–drug conjugate delivering a topoisomerase I inhibitor) as monotherapy or combined with fluoropyrimidines and/or checkpoint inhibitors (durvalumab, pembrolizumab, or investigational bispecifics volrustomig [PD‑1/CTLA‑4] and rilvegostomig [PD‑1/TIGIT]); first-line cohorts include a comparator of trastuzumab plus fluoropyrimidine/platinum. Prior trastuzumab exposure is required only for a post-trastuzumab cohort, with key exclusions including active ILD/pneumonitis and untreated CNS metastases.

ClinicalTrials.gov ID: NCT04379596