quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD) - LARVOL DELTA

MK-6482-012 China Extension: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study (clinicaltrials.gov) - P3 | N=249 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Dec 2026 ➔ Jun 2027 | Trial primary completion date: Dec 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

KEYMAKER-U02 Substudy 02D: Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02) (clinicaltrials.gov) - P1/2 | N=56 | Completed | Sponsor: Merck Sharp & Dohme LLC | N=300 ➔ 56 | Trial completion date: Apr 2030 ➔ Oct 2025 | Trial primary completion date: Apr 2030 ➔ Oct 2025 | Active, not recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

KEYMAKER-U03 sub-study 03A: Triplet investigational combinations of immunotherapy and targeted treatments as first-line therapy for advanced renal cell carcinoma (Eurekalert) - "This sub-study enrolled 353 patients with advanced ccRCC who were randomly assigned to receive one of the following four investigational combinations, or standard treatment, as first-line therapy: Favezelimab-pembrolizumab + lenvatinib; vibostolimab-pembrolizumab + lenvatinib; quavonlimab-pembrolizumab + lenvatinib; pembrolizumab + belzutifan + lenvatinib, or pembrolizumab + lenvatinib....The pembrolizumab-belzutifan-lenvatinib triplet demonstrated promising antitumor activity with an objective response rate (ORR) of 78% and a median progression-free survival (PFS) of 31.8 months as compared to 20.8 months in the reference arm. The pembrolizumab/quavonlimab plus lenvatinib group showed an ORR of 71%, but median PFS was similar to the control arm. The efficacy of the other two combinations was less favorable."

P1/2 data • Clear Cell Renal Cell Carcinoma

KEYMAKER-U02 Substudy 02B: Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) (clinicaltrials.gov) - P1/2 | N=315 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2030 ➔ Apr 2026 | Trial primary completion date: Apr 2030 ➔ Apr 2026

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

KEYSTEP-004: Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004) (clinicaltrials.gov) - P2 | N=116 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Jul 2025 | Trial primary completion date: Mar 2026 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

KEYMAKER-U02 Substudy 02B: Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) (clinicaltrials.gov) - P1/2 | N=315 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Melanoma • Oncology • Solid Tumor

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) (clinicaltrials.gov) - P2 | N=302 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2027 ➔ Apr 2026 | Trial primary completion date: Jun 2026 ➔ May 2025

dMMR • Mismatch repair • MSI-H • Trial completion date • Trial primary completion date • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

KEYMAKER-U03B: Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) (clinicaltrials.gov) - P1/2 | N=370 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2025 ➔ May 2026 | Trial primary completion date: Sep 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) (clinicaltrials.gov) - P2 | N=320 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Nov 2025 ➔ Jun 2027 | Trial primary completion date: Oct 2025 ➔ Jun 2026

Metastases • Mismatch repair • Trial completion date • Trial primary completion date • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Recruiting | N=80 ➔ 110 | Trial completion date: Nov 2026 ➔ Nov 2029 | Trial primary completion date: Nov 2026 ➔ May 2026

Combination therapy • Enrollment change • Enrollment open • Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

KEYMAKER-U02 Substudy 02D: Lenvatinib (Len) + Coformulated Quavonlimab And Pembrolizumab (Qmab/Pembro) or Len + Pembro For Melanoma Brain Metastasis (SMR 2024) - No abstract available

Melanoma • Oncology • Solid Tumor

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) (clinicaltrials.gov) - P2 | N=320 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Mismatch repair • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

MK-6482-012 China Extension: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study (clinicaltrials.gov) - P3 | N=249 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2027 ➔ Dec 2026 | Trial primary completion date: Jun 2027 ➔ Dec 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (clinicaltrials.gov) - P1/2 | N=400 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Results from KEYNOTE-B98: A phase 1b/2 study of pembrolizumab plus investigational agents in patients with anti-PD-(L)1-refractory extensive-stage small-cell lung cancer (ES-SCLC) (AACR 2024) - P1/2 | "In the KEYNOTE-B98 study of anti-PD-(L)1-refractory ES-SCLC, no new safety signals were identified for the pembro-based combinations investigated. Modest antitumor activity was observed with MK-1308A ± lenvatinib, but no activity for MK-1308A + MK-4830 or for MK-4280A. This study provided proof-of-concept for the feasibility of platform trials in 2L ES-SCLC."

Clinical • P1/2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - P1/2 | N=413 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ALK • BRAF • CTLA4 • EGFR

Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) (clinicaltrials.gov) - P1/2 | N=80 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Phase classification: P1b/2 ➔ P1/2

Combination therapy • Phase classification • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study (clinicaltrials.gov) - P3 | N=249 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) (clinicaltrials.gov) - P3 | N=1653 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Coformulated quavonlimab and pembrolizumab (pembro) in combination with lenvatinib (lenva) as first-line (1L) therapy for patients (pts) with advanced hepatocellular carcinoma (HCC): Phase 2 KEYSTEP-004 study. (ASCO-GI 2024) - P2 | "The coformulation of quavonlimab and pembrolizumab in combination with lenvatinib demonstrated manageable safety; further investigation is warranted to understand the efficacy of this triplet as 1L treatment for advanced HCC. Clinical trial information: NCT04740307."

Clinical • Combination therapy • Metastases • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

KEYMAKER-U02 Substudy 02D: Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02) (clinicaltrials.gov) - P1/2 | N=300 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Melanoma • Oncology • Solid Tumor

KEYMAKER-U03B: Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B) (clinicaltrials.gov) - P1/2 | N=370 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Phase classification: P1b/2 ➔ P1/2

Combination therapy • Phase classification • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (clinicaltrials.gov) - P1/2 | N=400 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Phase classification: P1b/2 ➔ P1/2

Combination therapy • Phase classification • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

KEYMAKER-U03B: Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B) (clinicaltrials.gov) - P1b/2 | N=370 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Genito-urinary Cancer • Neutropenia • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study (clinicaltrials.gov) - P3 | N=249 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

Combination therapy • Metastases • New P3 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor