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- favezelimab (MK-4280) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
An open-label phase 1/2 study of favezelimab plus pembrolizumab in patients with relapsed/refractory classical Hodgkin lymphoma with/without previous anti-PD-1 treatment () - May 4, 2023 - Abstract #ICML2023ICML_544;
- favezelimab (MK-4280) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Favezelimab plus pembrolizumab in anti (Room B) - May 4, 2023 - Abstract #ICML2023ICML_66;
- || 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) - May 1, 2023
P1, N=576, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Oct 2024 --> Mar 2024 | Trial primary completion date: Oct 2024 --> Mar 2024
- favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
KEYFORM-008: Coformulated favezelimab and pembrolizumab (MK4280A) versus chemotherapy in relapsed/refractory classical Hodgkin lymphoma. (On Demand | Hall A; Poster Bd # 132b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3989;
P3
In addition, pts must have relapsed after treatment with or failed to respond to brentuximab vedotin (BV), were ineligible for BV or discontinued BV due to toxicity, have ECOG performance status (PS) 0-2, adequate organ function, and availability of archival or newly obtained tissue sample. Pts will be randomized 1:1 to receive MK-4280A (coformulated favezelimab 800 mg/pembrolizumab 200 mg; Arm A) IV Q3W or physician
- || 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
Pts will be randomized 1:1 to receive MK-4280A (coformulated favezelimab 800 mg/pembrolizumab 200 mg; Arm A) IV Q3W or physician Trial completion date: May 2025 --> Oct 2025 | Trial primary completion date: May 2025 --> Oct 2025
- ||||| vibostolimab/pembrolizumab (MK-7684A) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
New P1/2 trial, Combination therapy, Metastases: A Phase 1/2, Umbrella Study of the Efficacy and Safety of Pembrolizumab plus Enfortumab vedotin +/- Investigational Agents in First-Line metastatic urothelial carcinoma (EUDRACT) - Apr 6, 2023
P1/2, N=390, Ongoing, Sponsor: Merck Sharp & Dohme LLC
- |||| 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 23, 2023
P2, N=320, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: May 2025 --> Oct 2025 | Trial primary completion date: May 2025 --> Oct 2025 Active, not recruiting --> Recruiting
- || Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date: KEYMAKER-U06 substudy 06A: A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A) (clinicaltrials.gov) - Jan 5, 2023
P1/2, N=120, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Recruiting Trial completion date: Nov 2025 --> Sep 2026 | Trial primary completion date: Jan 2024 --> Nov 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: Nov 2025 --> Sep 2026 | Trial primary completion date: Jan 2024 --> Nov 2024 Recruiting --> Active, not recruiting
- favezelimab (MK-4280) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD), vibostolimab (MK-7684) / Merck (MSD)
Pembrolizumab with favezelimab or vibostolimab for patients with high-risk (HR) bacillus Calmette-Gu (Blue Area, Room 1) - Dec 27, 2022 - Abstract #EAU2023EAU_1383;
P2
- Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
KEYMAKER-U06 substudy 06A trial in progress: A phase 1/2 study of investigational agents with pembrolizumab (pembro) plus chemotherapy (chemo) or lenvatinib in PD-1/L1 treatment-naïve advanced esophageal cancer. (Available On Demand; Poster Board No. P2) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_366;
P1/2
Enrollment in this study is ongoing. Clinical trial information: NCT05342636.
- favezelimab (MK-4280) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Phase 1 trial of the anti-LAG3 antibody favezelimab plus pembrolizumab in advanced gastric cancer. (Available On Demand; Poster Board No. G16) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_215;
P1
The combination therapy showed antitumor activity in line with other checkpoint inhibitors in advanced gastric cancer though higher antitumor activity was seen in PDL1 CPS≥ 1 tumors, particularly at higher dose. Clinical trial information: NCT02720068.
- || favezelimab (MK-4280) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
P1 data, Journal: A first-in-human study of the anti-LAG-3 antibody favezelimab plus pembrolizumab in previously treated, advanced microsatellite stable colorectal cancer. (Pubmed Central) - Dec 10, 2022
Favezelimab with or without pembrolizumab had a manageable safety profile, with no treatment-related deaths. Promising antitumor activity was observed with combination therapy, particularly in participants with PD-L1 CPS ≥1 tumors.
- ||| favezelimab (MK-4280) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Important: A first-in-human study of the anti-LAG-3 antibody favezelimab plus pembrolizumab in previously treated, advanced microsatellite stable #colorectal cancer. Just published in @ESMO_Open by @myESMO https://t.co/EbLQiGy4do (Twitter) - Dec 8, 2022
- favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Updated Results from an Open-Label Phase 1/2 Study of Favezelimab (anti–LAG-3) Plus Pembrolizumab in Relapsed or Refractory Classical Hodgkin Lymphoma (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4290;
P1/2
After additional follow-up, favezelimab plus pembrolizumab combination therapy continued to demonstrate sustained antitumor activity and acceptable safety in anti–PD-1–naive patients with R/R cHL. Further studies comparing the activity of this combination to that of single-agent pembrolizumab would be of clinical benefit.
- favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Updated Results from an Open-Label Phase 1/2 Study of Favezelimab (anti–LAG-3) Plus Pembrolizumab in Relapsed or Refractory Classical Hodgkin Lymphoma after Anti–PD-1 Treatment (ENMCC - 278-282) - Nov 4, 2022 - Abstract #ASH2022ASH_1735;
P1/2
After additional follow-up, favezelimab plus pembrolizumab combination therapy continued to demonstrate sustained antitumor activity and acceptable safety in pts with R/R cHL whose disease progressed following anti–PD-1 therapy. A phase 3 study is planned to further investigate the promising results found in this patient population.
- |||||||| Keytruda (pembrolizumab) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
New P3 trial, Metastases: KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study (clinicaltrials.gov) - Oct 31, 2022
P3, N=94, Recruiting, Sponsor: Merck Sharp & Dohme LLC
- favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Safety and Dose-Expansion Study of Combination Favezelimab (anti–LAG-3) Plus Pembrolizumab in Anti–PD-1–Naive Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Great Hall) - Oct 27, 2022 - Abstract #ISHL2022ISHL_62;
P1/2
Favezelimab 800 mg + pembro 200 mg Q3W demonstrated acceptable safety and effective antitumor activity in anti–PD-1–naive pts with R/R cHL. Comparative studies on its activity to that of single-agent pembro would be of clinical benefit.
- favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Safety and Dose-Expansion Study of Combination Favezelimab (anti–LAG-3) Plus Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma Refractory to Anti–PD-1 Treatment (Great Hall) - Oct 27, 2022 - Abstract #ISHL2022ISHL_59;
P1/2
Favezelimab 800 mg + pembrolizumab 200 mg Q3W demonstrated acceptable safety and effective antitumor activity in pts with R/R cHL and PD following anti–PD-1 therapy. This combination shows potential to reinduce a response in this pt population.
- ||||| favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Clinical, P3 data: MK4280 Favezelimab+Pembrolizumab (LAG3+PD-1 inh). Acceptable safety and effective antitumour activity in mostly heavily pretreated pts. Very happy to soon start the randomised phase 3 study (MK4280A-008) in Sweden! John Timmerman #ISHL12 (Twitter) - Oct 23, 2022
- ||||| favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Biomarker, Clinical, Checkpoint inhibition, IO biomarker: Strategies to enhance checkpoint inhibition. Older pts one example of the unmet needs. Combinations. HMA. Chemo, RT (abscopal effect, AERN). Other checkpoints (LAG3: MK4280A, TIM-3, TIGIT etc). Biomarkers needed. @BroeckelmannPJ #ISHL12 (Twitter) - Oct 23, 2022
- || Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, 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) - Oct 14, 2022
P2, N=320, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
This combination shows potential to reinduce a response in this pt population. Trial completion date: Jul 2023 --> Aug 2030 | Trial primary completion date: Jul 2022 --> Aug 2026
- |||||| favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Enrollment open: KEYFORM-008: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) (clinicaltrials.gov) - Oct 14, 2022
P3, N=360, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Jul 2023 --> Aug 2030 | Trial primary completion date: Jul 2022 --> Aug 2026 Not yet recruiting --> Recruiting
- ||||| Keytruda (pembrolizumab) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Enrollment closed, Metastases: KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) (clinicaltrials.gov) - Oct 13, 2022
P3, N=432, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||||||||| favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
New P3 trial: MK-4280A versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, relapsed/refractory Classical Hodgkin Lymphoma (EUDRACT) - Sep 29, 2022
P3, N=360, Ongoing, Sponsor: Merck Sharp & Dohme LLC
- || 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
- |||||||||| favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
New P3 trial: KEYFORM-008: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) (clinicaltrials.gov) - Aug 19, 2022
P3, N=360, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- Keytruda (pembrolizumab) / Merck (MSD)
KEYNOTE-495/KeyImPaCT: updated analysis of a biomarker-directed, randomized, phase 2 trial of pembrolizumab-based combination therapy for non-small cell lung cancer (Hall B2) - Aug 4, 2022 - Abstract #SITC2022SITC_109;
P2
Although response in the pembrolizumab+favezelimab arm did not reach the efficacy bar, there was a trend toward improved ORR in the Tcell inf GEP non-low TMB high subgroup versus the other 3 biomarker-defined subgroups; median PFS and OS were also numerically longer in the Tcell inf GEP non-low TMB high subgroup compared with the other 3 biomarker-defined subgroups. Prospective assessment of dual biomarkers, as performed in this study, may help identify patients with NSCLC most likely to respond to pembrolizumab-based combination therapies.
- ||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open: KEYMAKER-U06 substudy 06A: A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A) (clinicaltrials.gov) - Jul 20, 2022
P1/2, N=120, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Prospective assessment of dual biomarkers, as performed in this study, may help identify patients with NSCLC most likely to respond to pembrolizumab-based combination therapies. Not yet recruiting --> 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
Not yet recruiting --> Recruiting Trial completion date: Jun 2025 --> Mar 2026 | Trial primary completion date: Jun 2025 --> Mar 2026
- favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
FAVEZELIMAB (ANTI–LAG-3) AND PEMBROLIZUMAB CO-BLOCKADE IN PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA WHO PROGRESSED AFTER ANTI–PD-1 THERAPY: AN OPEN-LABEL PHASE 1/2 STUDY () - May 13, 2022 - Abstract #EHA2022EHA_1462;
P1/2
- favezelimab (MK-4280) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
FAVEZELIMAB (ANTI–LAG-3) AND PEMBROLIZUMAB CO-BLOCKADE IN ANTI–PD-1–NAIVE PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA: AN OPEN-LABEL PHASE 1/2 STUDY () - May 13, 2022 - Abstract #EHA2022EHA_1461;
P1/2
- favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Phase 3 study of MK4280A (coformulated favezelimab and pembrolizumab) versus standard of care in previously treated PD-L1–positive metastatic colorectal cancer (mCRC) () - May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_250;
P3
Abstract 3584). In this ongoing phase 3 study (NCT05064059), we will evaluate the efficacy and safety of MK-4280A in patients with PD-L1–positive pMMR mCRC.
- | 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
In this ongoing phase 3 study (NCT05064059), we will evaluate the efficacy and safety of MK-4280A in patients with PD-L1–positive pMMR mCRC. 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 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)
New P1/2 trial: KEYMAKER-U06 substudy 06A: A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A) (clinicaltrials.gov) - Apr 21, 2022
P1/2, N=120, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- || 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.
Further studies will be useful to compare its activity to that of pembrolizumab alone. 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
- || 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.
Recruiting --> Active, not recruiting | Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Feb 2025 --> Oct 2025 Recruiting --> Active, not recruiting
- ||| 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 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.
- ||| Enrollment change, 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) - Dec 29, 2021
P1/2, N=90, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Both substudies are recruiting patients in Australia, Canada, France, Israel, South Korea, Spain, New Zealand, the United Kingdom, and the United States. N=65 --> 90
- |||||| Keytruda (pembrolizumab) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
Enrollment open, Metastases: KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) (clinicaltrials.gov) - Nov 2, 2021
P3, N=432, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=65 --> 90 Not yet recruiting --> Recruiting
- 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
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), favezelimab/pembrolizumab (MK-4280A) / Merck (MSD)
New P3 trial, Metastases: KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) (clinicaltrials.gov) - Sep 30, 2021
P3, N=432, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- || 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, NCT03516981 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
- ||| 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.
Trial completion date: Jan 2024 --> May 2025 | Trial primary completion date: Jan 2024 --> May 2025 Not yet recruiting --> Recruiting
- ||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed: 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) - Jul 19, 2021
P2, N=260, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting