Pembrolizumab Plus Lenvatinib in Combination with Belzutifan in Solid Tumors
Key facts
- Where
- Edegem, Leuven, Roeselare, Sint-Lambrechts-Woluwe és Yvoir, BelgiumSee the 5 sites
- Phase
- 2. fázis
Where in Belgium
- Antwerp University HospitalEdegem, BelgiumNo longer taking part
- UZ LeuvenLeuven, BelgiumNo longer taking part
- Algemeen Ziekenhuis DeltaRoeselare, BelgiumNo longer taking part
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumNo longer taking part
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-NamurYvoir, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- EU 2023-503905-12-00
- Record updated
- 2026. május 22.
- Original description
1. To assess the safety and tolerability of the combination of pembrolizumab and lenvatinib and belzutifan (Arm 1/triplet). 2. To evaluate the confirmed objective response rate (ORR) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).Read full original descriptionShow less
An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors
1. To assess the safety and tolerability of the combination of pembrolizumab and lenvatinib and belzutifan (Arm 1/triplet). 2. To evaluate the confirmed objective response rate (ORR) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Inclusion: Diagnosis of one of the following advanced (unresectable and/or metastatic) solid tumors, documented by histopathology or cytopathology: Hepatocellular carcinoma (HCC), Colorectal cancer (CRC) (non-microsatellite instability-high [non-MSI-H]/deficient mismatch repair [dMMR]), Pancreatic ductal adenocarcinoma (PDAC), Biliary tract cancer (BTC) (includes intrahepatic, extrahepatic cholangiocarcinoma [CCA] and gall bladder cancer), Endometrial cancer (EC), Esophageal squamous cell carcinoma (ESCC); ESCC Specific Inclusion Criteria: Have experienced radiographic or clinical progression on one prior line of standard systemic therapy (immune oncology (IO) naïve participants) or an anti-PD-1/PD-L1 (IO resistant participants); Disease progression on or since the most recent treatment (does not apply to newly diagnosed unresectable or metastatic HCC or EC); Measurable disease per RECIST v1.1 as assessed locally (by investigator) and verified by BICR; Submission of an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated; HCC Specific Inclusion Criteria: No prior systemic chemotherapy, including anti-VEGF therapy, anti-programmed cell-death (PD-1)/PD-L1 or any systemic investigational anticancer agents for advanced/unresectable HCC (1L); CRC ([non-MSI-H/dMMR) Specific Inclusion Criteria: Received at least 2 prior lines of systemic therapy for unresectable or metastatic disease which includes fluoropyrimidine, irinotecan and oxaliplatin; PDAC Specific Inclusion Criteria: Prior therapy with at least 1 (platinum or gemcitabine containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer; BTC Specific Inclusion Criteria: Received at least 1 prior line of systemic therapy (containing gemcitabine or fluoropyrimidine) for unresectable or metastatic disease; EC Specific Inclusion Criteria: Study treatment is for 1L therapy of EC and participants should not have received prior systemic chemotherapy. Exception: May have received 1 prior line of line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of a curative-intent resection, if the recurrence occurred ≥6 months after the last dose of chemotherapy or may have received prior radiation with or without chemotherapy.
Exclusion: Prior therapy with a PD-1, anti-PD-L1, anti-PD-L2 agent, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) or hypoxia-inducible factor 2α (HIF-2α). Note, this criteria does not apply to participants with immune oncology (IO) exposed ESCC; Unable to swallow orally administered medication or presence of a gastrointestinal (GI) disorder that may affect study intervention absorption; History of a second malignancy that is progressing or has required active treatment within 3 years; Clinically significant cardiovascular disease within 6 months of first dose of study intervention; Moderate to severe hepatic impairment; Presence of central nervous system (CNS) metastases and/or carcinomatous meningitis.