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6 Trials |  |
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- | Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, Trial completion date, Trial primary completion date, Tumor mutational burden: 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 5, 2022
P2, N=318, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Oct 2025 --> Jun 2025 | Trial primary completion date: Oct 2025 --> Jun 2025
- favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Favezelimab (anti–LAG-3) plus pembrolizumab in patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL) after anti–PD-1 treatment: An open-label phase 1/2 study. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2651;
P1/2
Trial completion date: Oct 2025 --> Jun 2025 | Trial primary completion date: Oct 2025 --> Jun 2025 Favezelimab 800 mg + pembro 200 mg Q3W showed a tolerable safety profile and effective antitumor activity in heavily pretreated pts with R/R cHL whose disease had progressed after anti–PD-1 therapy, suggesting that the combination may reinduce a response in these pts.
- favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Favezelimab (anti–LAG-3) plus pembrolizumab in patients with anti–PD-1–naive relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL): An open-label phase 1/2 study. (Available On Demand; 170) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2620;
P1/2
Favezelimab 800 mg + pembrolizumab 200 mg Q3W demonstrated a tolerable safety profile and effective antitumor activity in pts with anti–PD-1–naïve R/R cHL. Further studies will be useful to compare its activity to that of pembrolizumab alone.
- Keytruda (pembrolizumab) / Merck (MSD)
Phase 2 study of pembrolizumab-based combination therapy in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) stage IV colorectal cancer (CRC). (Available On Demand; 427b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1439;
P2
Pts in cohort A must have experienced PD after fluoropyrimidine, irinotecan, and oxaliplatin, with or without anti-VEGF antibody, and anti-EGFR antibody for pts with left-sided tumors that are RAS WT...For both cohorts, primary end point is ORR by BICR per RECIST v1.1; secondary end points are ORR assessed by investigator, DOR and PFS assessed by BICR and by investigator per RECIST v1.1, OS, and safety and tolerability graded per NCI CTCAE v5.0. Enrollment in this trial is ongoing.
- || 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) - Apr 12, 2022
P1, N=576, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Enrollment in this trial is ongoing. Trial completion date: Dec 2023 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Oct 2024
- ||| Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, Enrollment closed, Trial completion date, Trial primary completion date, Tumor mutational burden: 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) - Apr 4, 2022
P2, N=318, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Dec 2023 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Oct 2024 Recruiting --> Active, not recruiting | Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Feb 2025 --> Oct 2025
- || favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003) (clinicaltrials.gov) - Mar 8, 2022
P1/2, N=154, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting | Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Feb 2025 --> Oct 2025 Trial completion date: Aug 2026 --> Dec 2026 | Trial primary completion date: Aug 2026 --> Dec 2026
- || Enrollment closed, 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 14, 2022
P1, N=576, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Aug 2026 --> Dec 2026 | Trial primary completion date: Aug 2026 --> Dec 2026 Recruiting --> Active, not recruiting
- || favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003) (clinicaltrials.gov) - Oct 6, 2021
P1/2, N=134, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Trial completion date: Dec 2025 --> Aug 2026 | Trial primary completion date: Dec 2025 --> Aug 2026
- Keytruda (pembrolizumab) / Merck (MSD)
KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC) () - Oct 1, 2021 - Abstract #SITC2021SITC_1238;
P2
View this table: View inline View popup Download powerpoint Abstract 457 Table 1 Confirmed ORR by Therapy and Biomarker Status Conclusions These data demonstrate the feasibility and clinical usefulness of prospective Tcell inf GEP and TMB assessment to study the clinical activity of three first-line pembrolizumab-based combination therapies in patients with advanced NSCLC. Although sample sizes were small, the Tcell inf GEP high TMB high subgroup demonstrated the best response among the biomarker subgroups for all three combination therapies; further validation is needed to determine additional signals and may be addressed as more mature data become available.
- Keytruda (pembrolizumab) / Merck (MSD)
KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC) (East Salons) - Oct 1, 2021 - Abstract #SITC2021SITC_142;
P2
Although sample sizes were small, the TcellinfGEPhighTMBhigh subgroup demonstrated the best response among the biomarker subgroups for all three combination therapies; further validation is needed to determine additional signals and may be addressed as more mature data become available. Trial Registration ClinicalTrials.gov, NCT03516981
- |||||| favezelimab (MK-4280) / Merck (MSD)
#CRCSM @ASCO #ASCO21 I had missed this particular abstract. LAG3⛔️➡️FAVEzelimab MK-4280 ➕ PD1⛔️ in pMMR/MSS #ColorectalCancer. With essentially no activity of #immunotherapy in pMMR/MSS, it’d be of value to identify who are 👇🏾these responders? https://t.co/ERfu16GDTO (Twitter) - Jun 15, 2021
- 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)
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.
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: Jan 2023 --> Feb 2025 | Trial primary completion date: Jan 2023 --> Feb 2025
- | 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.
Trial completion date: Jan 2023 --> Feb 2025 | Trial primary completion date: Jan 2023 --> Feb 2025 Trial completion date: May 2022 --> Dec 2023 | Trial primary completion date: May 2022 --> Dec 2023
- | favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Trial primary completion date: Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003) (clinicaltrials.gov) - May 28, 2020
P1/2, N=134, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: May 2022 --> Dec 2023 | Trial primary completion date: May 2022 --> Dec 2023 Trial primary completion date: Jul 2025 --> Nov 2025
- MK-4280 / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Phase 1-2 Study of Pembrolizumab Combined with the Anti–LAG-3 Antibody MK-4280 for the Treatment of Hematologic Malignancies (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2379;
P1/2
Exploratory objectives are to evaluate overall survival, progression-free survival, and best overall response for MK-4280 and pembrolizumab; to assess the presence of circulating MK-4280 and anti-pembrolizumab antibodies; to assess target engagement and pharmacodynamics of MK-4280 through biomarker evaluation; and to identify molecular biomarkers associated with clinical response/resistance, safety, pharmacodynamics, and/or the mechanism of action of MK-4280 and pembrolizumab . At least 14 patients (≥3 per cohort) will be enrolled in the safety lead-in phase; approximately 120 patients (≤30 per cohort) will be enrolled in the efficacy expansion phase.
- | 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.
At least 14 patients (≥3 per cohort) will be enrolled in the safety lead-in phase; approximately 120 patients (≤30 per cohort) will be enrolled in the efficacy expansion phase. Trial completion date: May 2022 --> Jan 2023 | Trial primary completion date: May 2022 --> Jan 2023
- Keytruda (pembrolizumab) / Merck (MSD)
KEYNOTE-495/KeyImPaCT: A randomized, biomarker-directed, phase II trial of pembrolizumab-based therapy for non–small cell lung cancer (NSCLC) (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_1725;
P2
Legal entity responsible for the study: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
- | MK-4280 / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Journal: Establishment of engineered cell-based assays mediating LAG3 and PD1 immune suppression enables potency measurement of blocking antibodies and assessment of signal transduction. (Pubmed Central) - Jul 19, 2019
Additional engineering of PD1 and PDL1 components into the LAG3 assay resulted in a bi-functional assay that is capable of inducing a 10-fold response to individual antibodies blocking either PD1 or LAG3. Importantly, when MK-4280 and pembrolizumab were combined to block both pathways, a synergistic 50-fold increase in response was observed.
- | 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.
Importantly, when MK-4280 and pembrolizumab were combined to block both pathways, a synergistic 50-fold increase in response was observed. N=192 --> 288
- | 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.
N=192 --> 288 Trial completion date: Jul 2021 --> May 2022 | Trial primary completion date: Jul 2021 --> May 2022
- | favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open: Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003) (clinicaltrials.gov) - Nov 1, 2018
P1/2, N=134, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Jul 2021 --> May 2022 | Trial primary completion date: Jul 2021 --> May 2022 Not yet recruiting --> Recruiting
- | 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.
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) - 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
- | favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Phase classification: Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003) (clinicaltrials.gov) - Aug 31, 2018
P1/2, N=134, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Mar 2021 --> Jul 2021 | Trial primary completion date: Mar 2021 --> Jul 2021 Phase classification: P1 --> P1/2
- | favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
New P1 trial, New P1/2 trial: Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003) (clinicaltrials.gov) - Jul 26, 2018
P1, N=134, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- || 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.
Phase classification: P1 --> P1/2 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.
- || 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.