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- || quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, Mismatch repair, Metastases: 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) - Dec 13, 2024
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
- ||| Enrollment open, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: 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) - Oct 16, 2024
P1/2, N=110, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Nov 2025 --> Jun 2027 | Trial primary completion date: Oct 2025 --> Jun 2026 Active, not recruiting --> Recruiting | N=80 --> 110 | Trial completion date: Nov 2026 --> Nov 2029 | Trial primary completion date: Nov 2026 --> May 2026
- ||| quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed, Mismatch repair, Metastases: 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) - Jun 26, 2024
P2, N=320, Active, not 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 Recruiting --> Active, not recruiting
- |||| Trial completion date, Trial primary completion date, Metastases: 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) - Jun 21, 2024
P3, N=249, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Trial completion date: Jun 2027 --> Dec 2026 | Trial primary completion date: Jun 2027 --> Dec 2026
- ||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed: Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (clinicaltrials.gov) - Apr 18, 2024
P1/2, N=400, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Jun 2027 --> Dec 2026 | Trial primary completion date: Jun 2027 --> Dec 2026 Recruiting --> Active, not recruiting
- |||| Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion, Metastases: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Apr 16, 2024
P1/2, N=413, Completed, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | Phase classification, Combination therapy, Monotherapy: 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) - Apr 4, 2024
P1/2, N=80, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed Phase classification: P1b/2 --> P1/2
- ||||| Enrollment closed, Metastases: 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) - Mar 12, 2024
P3, N=249, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Phase classification: P1b/2 --> P1/2 Recruiting --> Active, not recruiting
- ||||| Enrollment closed, Metastases: 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) - Mar 12, 2024
P3, N=1653, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- Keytruda (pembrolizumab) / Merck (MSD)
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) (Section 48) - Mar 5, 2024 - Abstract #AACR2024AACR_7888;
Recruiting --> Active, not recruiting Abstract is embargoed at this time.
- ||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed: 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) - Dec 22, 2023
P1/2, N=300, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Abstract is embargoed at this time. Recruiting --> Active, not recruiting
- | Keytruda (pembrolizumab) / Merck (MSD)
Phase classification: 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) - Dec 19, 2023
P1/2, N=370, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Phase classification: P1b/2 --> P1/2
- quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
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. (Poster Bd # C9) - Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_428;
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.
- | Keytruda (pembrolizumab) / Merck (MSD)
Phase classification: Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (clinicaltrials.gov) - Nov 18, 2023
P1/2, N=400, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Clinical trial information: NCT04740307. Phase classification: P1b/2 --> P1/2
- ||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed: 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) - Nov 2, 2023
P1b/2, N=370, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Phase classification: P1b/2 --> P1/2 Recruiting --> Active, not recruiting
- |||||||||| New P3 trial, Metastases: 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) - Jun 12, 2023
P3, N=249, Recruiting, Sponsor: Merck Sharp & Dohme LLC
- || Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: 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) - Apr 18, 2023
P1b/2, N=370, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Trial completion date: May 2025 --> Oct 2025 | Trial primary completion date: May 2025 --> Oct 2025
- || Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Feb 8, 2023
P1/2, N=348, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: May 2025 --> Oct 2025 | Trial primary completion date: May 2025 --> Oct 2025 Trial completion date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024
- || Enrollment closed, Combination therapy, Monotherapy: 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) - Jan 4, 2023
P1b/2, N=80, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024 Recruiting --> Active, not recruiting
- || quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Trial primary completion date, Mismatch repair, Metastases: 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) - Sep 14, 2022
P2, N=320, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Trial primary completion date: Sep 2024 --> Sep 2025
- || Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Sep 8, 2022
P1/2, N=348, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial primary completion date: Sep 2024 --> Sep 2025 Trial completion date: Jan 2024 --> Aug 2023 | Trial primary completion date: Jan 2024 --> Aug 2023
- || quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment closed, Combination therapy, Metastases: 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) - Jun 30, 2022
P2, N=110, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Jan 2024 --> Aug 2023 | Trial primary completion date: Jan 2024 --> Aug 2023 Recruiting --> Active, not recruiting
- || Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (clinicaltrials.gov) - May 27, 2022
P1b/2, N=390, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Trial completion date: Jun 2025 --> Mar 2026 | Trial primary completion date: Jun 2025 --> Mar 2026
- ||| Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Feb 1, 2022
P1/2, N=348, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Jun 2025 --> Mar 2026 | Trial primary completion date: Jun 2025 --> Mar 2026 Recruiting --> Active, not recruiting | Trial completion date: Jun 2022 --> Jan 2024 | Trial primary completion date: Jun 2022 --> Jan 2024
- ||| quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Enrollment change, Trial completion date, Mismatch repair, Metastases: 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) - Jan 27, 2022
P2, N=320, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting | Trial completion date: Jun 2022 --> Jan 2024 | Trial primary completion date: Jun 2022 --> Jan 2024 N=240 --> 320 | Trial completion date: Sep 2024 --> Aug 2025
- Phase 1b/2 umbrella study of investigational immune and targeted combination therapies for patients with advanced clear cell renal cell carcinoma (ccRCC). (In-Person & On Demand | Level 1, West Hall) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_795;
P1b/2
Secondary end points during the efficacy phase are duration of response, progression-free survival (RECIST v1.1 by BICR), clinical benefit rate, and overall survival. Both substudies are recruiting patients in Australia, Canada, France, Israel, South Korea, Spain, New Zealand, the United Kingdom, and the United States.
- Keytruda (pembrolizumab) / Merck (MSD), Welireg (belzutifan) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Phase 3 study of first-line treatment with pembrolizumab + belzutifan + lenvatinib or pembrolizumab/quavonlimab + lenvatinib versus pembrolizumab + lenvatinib for advanced renal cell carcinoma (RCC). (In-Person & On Demand | Level 1, West Hall - M3) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_790;
P3
Secondary end points are objective response rate and duration of response per RECIST v1.1 by BICR, patient-reported outcomes, and safety. The study is recruiting patients at sites across, Asia, Australia, Europe, North America, and South America.
- ||||| Clinical: @brian_rini detailed the focus, goals, and key end points of a 3-arm, phase 3 trial comparing MK-1308A or belzutifan plus lenvatinib and pembrolizumab to the control of lenvatinib and pembrolizumab alone to treat patients with advanced clear cell #RCC. https://t.co/EMUxNO4CH9 (Twitter) - Oct 27, 2021
- || Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Oct 22, 2021
P1/2, N=388, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
The study is recruiting patients at sites across, Asia, Australia, Europe, North America, and South America. Trial completion date: Dec 2023 --> Jun 2022 | Trial primary completion date: Dec 2023 --> Jun 2022
- quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD), Welireg (belzutifan) / Merck (MSD)
MK-1308A + lenvatinib and pembrolizumab + belzutifan + lenvatinib versus pembrolizumab + lenvatinib as first-line treatment for clear cell renal cell carcinoma: randomized, open-label, phase 3 study () - Oct 12, 2021 - Abstract #KCRS2021KCRS_51;
P3
Primary end points will be assessed in arm A compared with arm C and in arm B compared with arm C for patients with IMDC intermediate/poor status and in all patients regardless of IMDC status. Secondary end points are objective response rate, duration of response, patient-reported outcomes, and safety.
- Keytruda (pembrolizumab) / Merck (MSD), Welireg (belzutifan) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Phase 3 study of pembrolizumab + belzutifan + lenvatinib or pembrolizumab/quavonlimab + lenvatinib versus pembrolizumab + lenvatinib as first-line treatment for advanced renal cell carcinoma (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_408;
P3
Secondary end points are objective response rate and duration of response per RECIST v1.1 by BICR, patient-reported outcomes, and safety. Trial Registration Clinicaltrials.gov, NCT04736706
- ||||| Clinical: Randomized, open-label, 3-arm phase 3 study comparing MK-1308A + lenvatinib and pembro + belzutifan + lenvatinib vs pembro + lenvatinib as first-line treatment for advanced #ccRCC @brian_rini @VUMC_Cancer. #ESMO21 written coverage > https://t.co/95D5ABaPeG @zklaassen_md @myESMO (Twitter) - Sep 18, 2021
- || Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (clinicaltrials.gov) - Aug 18, 2021
P1b/2, N=390, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial Registration Clinicaltrials.gov, NCT04736706 Trial completion date: Jul 2024 --> Jun 2025 | Trial primary completion date: Jul 2024 --> Jun 2025
- || Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: 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) - Aug 18, 2021
P1b/2, N=370, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Jul 2024 --> Jun 2025 | Trial primary completion date: Jul 2024 --> Jun 2025 Trial completion date: Jan 2024 --> May 2025 | Trial primary completion date: Jan 2024 --> May 2025
- quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD), Welireg (belzutifan) / Merck (MSD)
[VIRTUAL] Randomized, open-label, 3-arm phase III study comparing MK-1308A + lenvatinib and pembrolizumab (pembro) + belzutifan + lenvatinib versus pembro + lenvatinib as first-line (1L) treatment for advanced clear cell renal cell carcinoma (ccRCC) () - Jul 22, 2021 - Abstract #ESMO2021ESMO_2056;
P3
Secondary end points are objective response rate, duration of response, patient-reported outcomes, and safety. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and Eisai Inc., Woodcliff Lake, NJ, USA.
- ||| Enrollment open, Combination therapy, Monotherapy: 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) - Jul 22, 2021
P1b/2, N=80, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and Eisai Inc., Woodcliff Lake, NJ, USA. Not yet recruiting --> Recruiting
- ||||| quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
New P2 trial, Mismatch repair, Pan tumor, Metastases: Phase 2 Basket study of Pembrolizumab or MK1308A in mCRC (EUDRACT) - Jul 6, 2021
P2, N=240, Ongoing, Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
- |||| quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open, Mismatch repair, Metastases: 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) - Jun 23, 2021
P2, N=240, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| Trial completion date, Metastases: 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) - Jun 9, 2021
P3, N=1431, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Trial completion date: Sep 2027 --> Oct 2026
- lenvatinib / Generic mfg.
[VIRTUAL] Pembrolizumab/quavonlimab coformulation in combination with lenvatinib in advanced hepatocellular carcinoma: Phase 2 trial in progress () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_288;
P2
Additionally, lenvatinib, an inhibitor of vascular endothelial growth factor receptors 1-3, fibroblast growth factor receptors 1-4, platelet-derived growth factor receptor alpha, KIT, and RET, is a first-line treatment option in advanced HCC and has shown promising antitumor activity in combination with pembrolizumab in an early-stage study. MK-1308A-004 (NCT04740307) is an open-label phase 2 study investigating the safety and efficacy of MK-1308A, a coformulation of pembrolizumab (PD-1 inhibitor) and quavonlimab (CTLA-4 inhibitor) plus lenvatinib as first-line therapy for patients with advanced HCC.
- ||||| quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD)
Mismatch repair: NCT04895722 posted yesterday. Evaluation of Pembrolizumab (MK-3475) or Co-formulated Quavonlimab (MK-1308)/Pembrolizumab (MK-3475) in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV #Colorectal Cancer (CRC) (MK-1308A-008) (Twitter) - May 21, 2021
P2
- ||||| quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
New P2 trial, Mismatch repair, Metastases: 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) - May 19, 2021
P2, N=240, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- [VIRTUAL] A phase 1b/2 umbrella study of investigational immune and targeted combination therapies as first-line therapy for patients with advanced renal cell carcinoma (RCC). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2106;
P1b/2, P3
Coprimary end points are safety and tolerability, establishing the RP2D during the safety lead-in phase (if applicable) and objective response rate per RECIST v1.1 by blinded independent central review (BICR) during the efficacy phase . Secondary end points during the efficacy phase are duration of response, progression-free survival and clinical benefit rate per RECIST v1.1 (BICR), and overall survival.
- |||||| Enrollment open, Metastases: 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) - Apr 25, 2021
P3, N=1431, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Secondary end points during the efficacy phase are duration of response, progression-free survival and clinical benefit rate per RECIST v1.1 (BICR), and overall survival. Not yet recruiting --> Recruiting
- |||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open: 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) - Apr 1, 2021
P1/2, N=300, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
Enrollment open, Combination therapy, Metastases: 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) - Mar 24, 2021
P2, N=110, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- favezelimab (MK-4280) / Merck (MSD), MK-4830 / Merck (MSD), belzutifan (MK-6482) / Merck (MSD)
[VIRTUAL] A phase 1b/2 umbrella study of investigational immune and targeted combination therapies for patients with advanced renal cell carcinoma (RCC) who progressed on PD-1/L1 and VEGF inhibitors () - Mar 11, 2021 - Abstract #AACR2021AACR_3177;
P1b/2
Primary end points for safety lead-in phase (if applicable) are safety and tolerability to establish an RP2D; co-primary end points for efficacy phase are safety and objective response rate per RECIST v1.1 by blinded independent central review (BICR). Secondary end points during the efficacy phase are duration of response, progression-free survival, and clinical benefit rate per RECIST v1.1 (BICR), and overall survival.
- || Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Feb 24, 2021
P1/2, N=412, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Secondary end points during the efficacy phase are duration of response, progression-free survival, and clinical benefit rate per RECIST v1.1 (BICR), and overall survival. Trial completion date: Mar 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Dec 2023
- |||| quavonlimab/pembrolizumab (MK-1308A) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
New P2 trial, Combination therapy, Metastases: 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) - Feb 4, 2021
P2, N=110, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- |||||||||| New P3 trial, Metastases: 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) - Feb 3, 2021
P3, N=1431, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.