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NCT04976634
Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)
Phase 2 trial testing Pembrolizumab in Neoplasm Malignant in 730 participants. Participants enrolled and being followed up; not accepting new ones.
22 March 2027
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 730 |
| Start date | 18 August 2021 |
| Primary completion | 22 March 2027 |
| Estimated completion | 22 March 2027 |
| Sites | 57 locations across France, New Zealand, Netherlands, Belgium, Chile, Israel, South Korea, Australia |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
- Belzutifan (BELZUTIFAN) — full drug profile →
- Lenvatinib (LENVATINIB) — full drug profile →
Conditions studied
- Neoplasm Malignant — all drugs for Neoplasm Malignant →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
18 and older, any sex, with Neoplasm Malignant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The hypoxia-driven crosstalk between tumor and tumor-associated macrophages: mechanisms and clinical treatment strategies.
Bai R, Li Y, Jian L, Yang Y, et al · · 2022 · cited 200× · PMID 36071472 · DOI 10.1186/s12943-022-01645-2 -
Targeting hypoxia-inducible factors: therapeutic opportunities and challenges.
Yuan X, Ruan W, Bobrow B, Carmeliet P, et al · · 2024 · cited 144× · PMID 38123660 · DOI 10.1038/s41573-023-00848-6 -
Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181 -
Digestive cancers: mechanisms, therapeutics and management.
Zhan T, Betge J, Schulte N, Dreikhausen L, et al · · 2025 · cited 30× · PMID 39809756 · DOI 10.1038/s41392-024-02097-4 -
Update on combined immunotherapy for the treatment of advanced renal cell carcinoma.
Gebrael G, Sahu KK, Agarwal N, Maughan BL. · · 2023 · cited 29× · PMID 37062953 · DOI 10.1080/21645515.2023.2193528 -
Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898 -
Belzutifan: a novel therapeutic for the management of von Hippel-Lindau disease and beyond.
Curry L, Soleimani M. · · 2024 · cited 20× · PMID 38639572 · DOI 10.2217/fon-2023-0679 -
Hypoxic tumor microenvironment: Destroyer of natural killer cell function.
Zhang Y, Guo F, Wang Y. · · 2024 · cited 13× · PMID 38751439 · DOI 10.21147/j.issn.1000-9604.2024.02.04
Verify or expand the search:
- PubMed search for NCT04976634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Other recruiting trials for Neoplasm Malignant
Currently open trials in the same condition.
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Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
- NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
- NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
- NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
- NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
- NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04976634 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
- Last refreshed: 6 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04976634.
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