Rilvegostomig

HealthScout AI summary: Adults with locally advanced/metastatic NSCLC enrolled by biomarker and line: first-line AGA-negative with PD-L1 ≥50% get rilvegostomig (PD‑1/TIGIT bispecific) ± ramucirumab, first-line AGA-negative with PD-L1 1–49% get rilvegostomig + ramucirumab, and second-line AGA-positive nonsquamous post–targeted therapy get datopotamab deruxtecan (TROP2 ADC) + ramucirumab ± rilvegostomig. Designed to assess safety and antitumor activity across these combinations, excluding patients with active autoimmune disease, uncontrolled comorbidities, or unstable CNS disease.

ClinicalTrials.gov ID: NCT07098338

HealthScout AI summary: Adults with select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043

HealthScout AI summary: First-line trial in adults with unresectable/advanced HCC (BCLC B not LRT-eligible or C; Child-Pugh A; ECOG 0–1; no prior systemic therapy) comparing rilvegostomig (PD-1/TIGIT bispecific) plus bevacizumab with or without tremelimumab (CTLA-4) versus standard atezolizumab (PD-L1) plus bevacizumab. Excludes significant bleeding risk/anticoagulation needs, active autoimmune disease requiring immunosuppression, CNS mets, hepatic encephalopathy, and prior anti-CTLA-4/TIGIT.

ClinicalTrials.gov ID: NCT06921785

HealthScout AI summary: This trial enrolls adults with previously untreated, PD-L1-high metastatic non-small cell lung cancer (any histology, no EGFR/ALK/ROS1 alterations) and compares rilvegostomig, a bispecific antibody targeting PD-1 and TIGIT, to pembrolizumab monotherapy.

ClinicalTrials.gov ID: NCT06868277

HealthScout AI summary: Adults with HER2 IHC 3+/2+, pMMR primary advanced or recurrent endometrial carcinoma (systemic therapy–naïve in the advanced/recurrent setting; carcinosarcoma allowed) are randomized to T-DXd plus rilvegostomig (bispecific PD-1/TIGIT antibody) or T-DXd plus pembrolizumab versus carboplatin/paclitaxel plus pembrolizumab, with PFS as the primary endpoint. T-DXd is an anti-HER2 antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd); key exclusions include prior ICIs/ADCs and significant ILD/pneumonitis risk.

ClinicalTrials.gov ID: NCT06989112

HealthScout AI summary: First-line trial for adults with unresectable/metastatic HER2-positive, PD-L1 CPS ≥1 gastric/GEJ adenocarcinoma (ECOG 0–1) comparing: (A) rilvegostomig (bispecific PD-1/TIGIT antibody) + fluoropyrimidine + trastuzumab deruxtecan, versus (B) pembrolizumab + trastuzumab + FP or CAPOX, and (C) rilvegostomig + trastuzumab + FP or CAPOX. Key outcomes are PFS/OS; excludes significant autoimmune disease, ILD/pneumonitis risk, uncontrolled HBV/HCV, and LVEF <55%.

ClinicalTrials.gov ID: NCT06764875

HealthScout AI summary: Adults with stage IV, non-squamous, metastatic NSCLC expressing PD-L1 (≥1%) without EGFR, ALK, or ROS1 mutations are randomized to receive either rilvegostomig—a bispecific PD-1/TIGIT antibody—or pembrolizumab, each in combination with platinum+pemetrexed chemotherapy, as first-line treatment. Prior immunotherapy is not permitted; patients with symptomatic brain metastases or active autoimmune disease are excluded.

ClinicalTrials.gov ID: NCT06627647

HealthScout AI summary: This trial enrolls adults with untreated, stage IV squamous NSCLC whose tumors have PD-L1 expression ≥1%, randomizing them to receive first-line platinum-based chemotherapy combined with either rilvegostomig—a bispecific antibody targeting PD-1 and TIGIT—or pembrolizumab, each followed by their respective monotherapy as maintenance. Key exclusions are prior immunotherapy, active CNS disease, and significant autoimmune or infectious disorders.

ClinicalTrials.gov ID: NCT06692738

HealthScout AI summary: This trial enrolls adults with previously untreated, locally advanced or metastatic non-squamous NSCLC, high PD-L1 expression (TC ≥ 50%), and no EGFR/ALK/ROS1 alterations, randomizing to either datopotamab deruxtecan (a TROP2-directed ADC) plus rilvegostomig (a bispecific PD-1/TIGIT antibody), rilvegostomig alone, or pembrolizumab monotherapy as first-line therapy. Eligible patients must have ECOG 0-1 and no prior systemic therapy for advanced disease.

ClinicalTrials.gov ID: NCT06357533

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 advanced or metastatic squamous or non-squamous NSCLC (excluding tumors with actionable genomic alterations), either CPI-experienced or treatment-naive with documented PD-L1 expression, to receive rilvegostomig (AZD2936), an intravenous bispecific anti-TIGIT/anti-PD-1 antibody designed to enhance T-cell antitumor activity. Patients must have ECOG 0-1 and adequate organ function.

ClinicalTrials.gov ID: NCT04995523

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