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- |||| 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
- ||||| 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.
- favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD), mavezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
[VIRTUAL] A phase 1 first-in-human study of the anti-LAG-3 antibody MK4280 (favezelimab) plus pembrolizumab in previously treated, advanced microsatellite stable colorectal cancer. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2409;
P1
Favezelimab alone or in combination with pembrolizumab had a manageable safety profile, with no treatment-related deaths . Promising antitumor activity was observed with combination therapy, including with MK-4280A, compared with monotherapy most notably in pts with PD-L1 CPS ≥1 tumors.
- [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.
- 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)
Enrollment open: Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (clinicaltrials.gov) - Jan 6, 2021
P1b/2, N=390, 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-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) - Jan 6, 2021
P1b/2, N=370, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, Trial completion date, Trial primary completion date, Tumor mutational burden, PD(L)-1 Biomarker: KeyImPaCT: A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov) - Dec 10, 2020
P2, N=318, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Trial completion date: Jan 2023 --> Feb 2025 | Trial primary completion date: Jan 2023 --> Feb 2025
- | Keytruda (pembrolizumab) / Merck (MSD)
Enrollment change: 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) - Oct 29, 2020
P1/2, N=315, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Jan 2023 --> Feb 2025 | Trial primary completion date: Jan 2023 --> Feb 2025 N=135 --> 315
- | Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open: 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) - Jun 23, 2020
P1/2, N=135, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=135 --> 315 Not yet recruiting --> Recruiting
- | Enrollment open, Combination therapy: KEYMAKER-U02 Substudy 02C: Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02) (clinicaltrials.gov) - Jun 23, 2020
P1/2, N=65, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Trial completion date, Trial primary completion date, Monotherapy, Metastases: Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) (clinicaltrials.gov) - Jun 23, 2020
P1, N=488, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Trial completion date: May 2022 --> Dec 2023 | Trial primary completion date: May 2022 --> Dec 2023
- | Keytruda (pembrolizumab) / Merck (MSD)
New P1/2 trial: 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) - Mar 12, 2020
P1/2, N=135, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | New P1/2 trial, Combination therapy: KEYMAKER-U02 Substudy 02C: Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02) (clinicaltrials.gov) - Mar 10, 2020
P1/2, N=65, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, Trial completion date, Trial primary completion date, Tumor mutational burden, PD(L)-1 Biomarker: KeyImPaCT: A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov) - Sep 30, 2019
P2, N=318, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: May 2022 --> Dec 2023 | Trial primary completion date: May 2022 --> Dec 2023 Trial completion date: May 2022 --> Jan 2023 | Trial primary completion date: May 2022 --> Jan 2023
- | Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, Enrollment change, Tumor mutational burden, PD(L)-1 Biomarker: KeyImPaCT: A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov) - Mar 18, 2019
P2, N=288, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: May 2022 --> Jan 2023 | Trial primary completion date: May 2022 --> Jan 2023 N=192 --> 288
- | Keytruda (pembrolizumab) / Merck (MSD)
Trial primary completion date: Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - Mar 6, 2019
P2, N=260, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=192 --> 288 Trial primary completion date: Feb 2019 --> Jun 2022
- | Trial completion date, Trial primary completion date, Monotherapy, Metastases: Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) (clinicaltrials.gov) - Feb 28, 2019
P1, N=408, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Feb 2019 --> Jun 2022 Trial completion date: Jul 2021 --> May 2022 | Trial primary completion date: Jul 2021 --> May 2022
- | Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date: Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - Oct 12, 2018
P2, N=260, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Jul 2021 --> May 2022 | Trial primary completion date: Jul 2021 --> May 2022 Trial completion date: Dec 2021 --> Jul 2023
- | Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, Enrollment open, Tumor mutational burden, PD(L)-1 Biomarker: KeyImPaCT: A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov) - Oct 10, 2018
P2, N=192, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Dec 2021 --> Jul 2023 Not yet recruiting --> Recruiting
- | Trial completion date, Trial primary completion date, Monotherapy, Metastases: Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) (clinicaltrials.gov) - Sep 24, 2018
P1, N=408, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Trial completion date: Mar 2021 --> Jul 2021 | Trial primary completion date: Mar 2021 --> Jul 2021
- | Lenvima (lenvatinib) / Eisai, Merck (MSD), Lynparza (olaparib) / Merck (MSD), AstraZeneca, favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Enrollment open: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) (clinicaltrials.gov) - Aug 21, 2018
P3, N=2300, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Mar 2021 --> Jul 2021 | Trial primary completion date: Mar 2021 --> Jul 2021 Not yet recruiting --> Recruiting
- ||||| Lenvima (lenvatinib) / Eisai, Merck (MSD), Lynparza (olaparib) / Merck (MSD), AstraZeneca, favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Trial initiation date: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) (clinicaltrials.gov) - Jul 6, 2018
P3, N=2300, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Initiation date: May 2018 --> Aug 2018
- || Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, Trial initiation date, Tumor mutational burden, PD(L)-1 Biomarker: KeyImPaCT: A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov) - Jul 6, 2018
P2, N=192, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
Initiation date: May 2018 --> Aug 2018 Initiation date: Jul 2018 --> Dec 2018
- || Enrollment change, Monotherapy, Metastases: Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) (clinicaltrials.gov) - Jun 20, 2018
P1, N=340, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Initiation date: Jul 2018 --> Dec 2018 N=240 --> 340
- ||||| Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, New P1/2 trial, New P2 trial, Tumor mutational burden, PD(L)-1 Biomarker: KeyImPaCT: A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov) - May 8, 2018
P1/2, N=288, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- |||||||||| Lenvima (lenvatinib) / Eisai, Merck (MSD), Lynparza (olaparib) / Merck (MSD), AstraZeneca, favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
New P3 trial: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) (clinicaltrials.gov) - Apr 2, 2018
P3, N=2300, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- || Enrollment change, Monotherapy, Metastases: Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) (clinicaltrials.gov) - Apr 18, 2017
P1, N=260, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=240 --> 340 N=70 --> 260
- ||| Enrollment open, Phase classification, Monotherapy, Metastases: Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) (clinicaltrials.gov) - May 18, 2016
P1, N=70, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=70 --> 260 Not yet recruiting --> Recruiting | Phase classification: P1/2 --> P1
- ||||| New P1/2 trial, Monotherapy, Metastases: Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) (clinicaltrials.gov) - Mar 25, 2016
P1/2, N=70, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- |||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open: Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - Feb 24, 2016
P2, N=260, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting | Phase classification: P1/2 --> P1 Not yet recruiting --> Recruiting
- ||||| Keytruda (pembrolizumab) / Merck (MSD)
New P2 trial: Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - Dec 10, 2015
P2, N=260, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.