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- Keytruda (pembrolizumab) / Merck (MSD)
KEYMAKER-U03 Substudy 03B: Pembrolizumab (pembro) and novel immunotherapy agents for advanced clear cell renal cell carcinoma (ccRCC). (Level 1, West Hall; Poster Bd #: G19) - Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_469;
P1/2
We present results from arms containing only immunotherapy regimens: arm B1 (quavonlimab [qmab; anti
- Keytruda (pembrolizumab) / Merck (MSD)
Triplet combination treatments with pembrolizumab (pembro) for anti (Hall D1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_824;
P1/2
We report results from arm 1 (pembro + quavonlimab [qmab] (anti-CTLA4) + vibostolimab [vibo] (anti-TIGIT)), arm 2 [pembro + qmab + lenvatinib [len] (TKI)), and arm 3 (pembro + ATRA [all-trans retinoic acid]) of KEYMAKER-U02A. Although objective responses were observed in some pts with anti
- |||| Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion: 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
Although objective responses were observed in some pts with anti Active, not recruiting --> Completed
- || Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed: KEYMAKER-U02 Substudy 02A: Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02) (clinicaltrials.gov) - Dec 27, 2023
P1/2, N=200, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || Review, Journal, Metastases: LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma. (Pubmed Central) - Dec 25, 2023
P3
Results from this study may support triplet combination therapies as a potential new standard of care for advanced ccRCC. Clinical trial registry: NCT04736706 (ClinicalTrials.gov).
- || Keytruda (pembrolizumab) / Merck (MSD)
P2 data, Review, Journal, Metastases: KEYSTEP-008: phase II trial of pembrolizumab-based combination in MSI-H/dMMR metastatic colorectal cancer. (Pubmed Central) - Dec 17, 2023
P2
Clinical trial registry: NCT04736706 (ClinicalTrials.gov). Here we describe the design and rationale for the open-label, randomized, phase II KEYSTEP-008 trial, which will evaluate the efficacy and safety of pembrolizumab-based combination therapy compared with pembrolizumab monotherapy in chemotherapy-refractory (cohort
- || Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date: 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
Here we describe the design and rationale for the open-label, randomized, phase II KEYSTEP-008 trial, which will evaluate the efficacy and safety of pembrolizumab-based combination therapy compared with pembrolizumab monotherapy in chemotherapy-refractory (cohort Trial completion date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024
- ||||| Clinical, P2 data: Invited abstract 635 @DrRoyHerbstYale @YaleMed reviews updates on KEYNOTE-495 randomized phase 2 in #NSCLC with pembro+lenvatinib or quavonlimab or favezelimab. Median PFS and OS were longer in T cell inf GEP nonlow TMB high subgroup @sitcancer #SITC22 (Twitter) - Nov 10, 2022
- || Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date: 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 completion date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024 Trial completion date: Jan 2024 --> Aug 2023 | Trial primary completion date: Jan 2024 --> Aug 2023
- 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)
Phase 2 study of pembrolizumab-based combination therapy in patients with microsatellite instability-high or mismatch repair-deficient stage IV colorectal cancer () - May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_198;
P2
Targeting a different pathway such as CTLA-4, LAG-3, TIGIT, or ILT4 using a second checkpoint inhibitor may improve the efficacy of PD-1 inhibition. This ongoing, open-label, multicenter, multiarm, randomized, phase 2 trial (NCT04895722) will enroll patients in 2 cohorts, A and B. This study will evaluate efficacy and safety of coformulated pembrolizumab and anti–CTLA-4 quavonlimab compared with pembrolizumab monotherapy in chemotherapy-refractory stage IV dMMR/MSI-H CRC in cohort A. In cohort B, the study will evaluate the efficacy and safety of 4 pembrolizumab-based combinations (coformulated pembrolizumab with either quavonlimab, anti–LAG-3 favezelimab, or anti-TIGIT vibostolimab; anti-ILT4 antibody MK-4830 given sequentially with pembrolizumab) compared with pembrolizumab monotherapy in previously untreated stage IV dMMR/MSI-H CRC.
- | 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
This ongoing, open-label, multicenter, multiarm, randomized, phase 2 trial (NCT04895722) will enroll patients in 2 cohorts, A and B. This study will evaluate efficacy and safety of coformulated pembrolizumab and anti–CTLA-4 quavonlimab compared with pembrolizumab monotherapy in chemotherapy-refractory stage IV dMMR/MSI-H CRC in cohort A. In cohort B, the study will evaluate the efficacy and safety of 4 pembrolizumab-based combinations (coformulated pembrolizumab with either quavonlimab, anti–LAG-3 favezelimab, or anti-TIGIT vibostolimab; anti-ILT4 antibody MK-4830 given sequentially with pembrolizumab) compared with pembrolizumab monotherapy in previously untreated stage IV dMMR/MSI-H CRC. Trial completion date: Oct 2025 --> Jun 2025 | Trial primary completion date: Oct 2025 --> Jun 2025
- 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.
- ||| 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.
Enrollment in this trial is ongoing. Recruiting --> Active, not recruiting | Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Feb 2025 --> Oct 2025
- ||||| Clinical: ICYMI: A phase 3 clinical trial will compare the safety of pembro & quavonlimab + lenvatinib, & that of pembrolizumab, belzutifan, & lenvatinib, vs pembrolizumab/lenvatinib alone in the frontline treatment of advanced RCC @DrChoueiri @DanaFarber #kcsm https://t.co/7e3RLkAuUi (Twitter) - Mar 24, 2022
- Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Phase 1/2 study of quavonlimab (Qmab) + pembrolizumab (pembro) in patients (pts) with advanced melanoma that progressed on a PD-1/PD-L1 inhibitor (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_6739;
P1/2
Qmab + pembro was generally well tolerated and provided modest antitumor activity in pts with advanced melanoma that progressed on a PD-1/PD-L1 inhibitor. This combination and a coformulation of Qmab + pembro will be further investigated in the KEYMAKER-U02 study.
- ||||| Keytruda (pembrolizumab) / Merck (MSD), Welireg (belzutifan) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Clinical, P3 data: RCC TiP Phase 3 study of 1L Treatment w/ Pembro + Belzutifan + Len vs Pembro/Quavonlimab + Len vs Pembro + Len for advanced RCC @DrChoueiri et al #GU22 📌Est 1,431 rx-naive mRCC pts 📌Prim EP: PFS by BICR & OS 📌Sec EP: ORR, DOR, safety, tolerability @urotoday (Twitter) - Feb 19, 2022
- ||| Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date: 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.
This combination and a coformulation of Qmab + pembro will be further investigated in the KEYMAKER-U02 study. Recruiting --> Active, not recruiting | Trial completion date: Jun 2022 --> Jan 2024 | Trial primary completion date: Jun 2022 --> Jan 2024
- 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.
- |||| Pembrolizumab/Lenvatinib Plus Belzutifan or Quavonlimab Under Investigation in Advanced Clear Cell RCC @DrChoueiri @harvardmed @DanaFarber #kcsm https://t.co/HlijoIVw1O (Twitter) - Dec 20, 2021
- || Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date: 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
- 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), 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
- 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), quavonlimab (MK-1308) / Merck (MSD)
Clinical, P1 data, Clinical Trial,Phase I, Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker: Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer. (Pubmed Central) - Aug 25, 2021
P1/2
Encouraging antitumor activity was observed with quavonlimab + pembrolizumab in patients with extensive-stage SCLC; responses were observed in PD-L1-positive and PD-L1-negative tumors. The combination was tolerable with manageable toxicities.
- || Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Clinical, Journal, Combination therapy, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Safety and Efficacy of Quavonlimab, a Novel Anti-CTLA-4 Antibody (MK-1308), in Combination with Pembrolizumab in First-Line Advanced Non-Small Cell Lung Cancer. (Pubmed Central) - Mar 6, 2021
The combination was tolerable with manageable toxicities. Quavonlimab 25 mg Q6W plus pembrolizumab demonstrated similar efficacy and a better safety profile among all quavonlimab doses/schedules evaluated; this regimen was the chosen RP2D.
- Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
[VIRTUAL] Anti-CTLA-4 antibody quavonlimab plus pembrolizumab for lung cancer: Japanese subset from Phase I study (Track 13) - Mar 2, 2021 - Abstract #JSMO2021JSMO_875;
- || Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date: 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.
Quavonlimab 25 mg Q6W plus pembrolizumab demonstrated similar efficacy and a better safety profile among all quavonlimab doses/schedules evaluated; this regimen was the chosen RP2D. Trial completion date: Mar 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Dec 2023
- |||| Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Not a lung investigator but hope field doesn't lose sight of observation that CTLA4 blockade augments PD1 blockade most in the high risk/non-T cell-inflamed (PDL1 lower) subset (Mel/RCC). This trial not pop to study this in. Watch for the Pembro+Quavonlimab (CTLA4i) trial soon. (Twitter) - Jan 29, 2021
- | 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.
Trial completion date: Mar 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Dec 2023 Trial completion date: Jan 2023 --> Feb 2025 | Trial primary completion date: Jan 2023 --> Feb 2025
- ||||| Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD), Yervoy (ipilimumab) / Ono Pharma, BMS
Biomarker, IO Biomarker: Understand the rationale to develop quavonlimab but does the negative KEYNOTE-598 trial (pembro + ipilimumab vs pembro alone) influence plans for future study in NSCLC? I do think there is a role for CTLA-4 but it is in desperate need of a biomarker. https://t.co/cEDnSiVqLG (Twitter) - Dec 4, 2020
- |||| Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
#OncoAlert Phase I study of anti-CTLA4 quavonlimab (MK-1308) plus pembrolizumab in NSCLC available @Annals_Oncology. Tolerable, but fairly high rates of G3+ AEs. Encouraging 33% RR in PDL1 negative NSCLC but no comparator in this phase I study. #LCSM https://t.co/OvRj6zbPC3 (Twitter) - Dec 4, 2020
- |||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, quavonlimab (MK-1308) / Merck (MSD)
Clinical: Akesobio (HK listed) very close to successfully crossing several inflection points. - $MRK enthusiasm for its CTLA-4 MK-1308 at IASLC - Owned PD1 and PD1/CTLA4 (BTF FTD) in late stage with competitive safety/efficacy ratio vs Pembro, Nivo, Ipi.. - #SITC2020 : CD73, CD47, TIGIT.. (Twitter) - Nov 23, 2020
- Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
[VIRTUAL] Novel Anti–CTLA-4 Antibody Quavonlimab Plus Pembrolizumab as First-Line Therapy for NSCLC: Extended Follow-up From a Phase 1 Study () - Sep 29, 2020 - Abstract #IASLCNACLC2020IASLC-NACLC_180;
P1/2
Efficacy and safety data support 25 mg Q6W as the recommended phase 2 dose of quavonlimab when used with pembrolizumab. A phase 3 study is planned.
- | Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open: KEYMAKER-U02 Substudy 02A: Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02) (clinicaltrials.gov) - Jun 23, 2020
P1/2, N=200, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
A phase 3 study is planned. Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Apr 17, 2020
P1/2, N=328, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
- | Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Phase classification: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Mar 31, 2020
P1/2, N=328, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Oct 2022 --> Feb 2023 Phase classification: P1 --> P1/2
- | Keytruda (pembrolizumab) / Merck (MSD)
New P1/2 trial: KEYMAKER-U02 Substudy 02A: Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02) (clinicaltrials.gov) - Mar 12, 2020
P1/2, N=200, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Dec 2, 2019
P1, N=308, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Phase classification: P1 --> P1/2 Trial completion date: Feb 2023 --> Oct 2022 | Trial primary completion date: Feb 2023 --> Oct 2022
- Keytruda (pembrolizumab) / Merck (MSD), MK-1308 / Merck (MSD)
Results from a phase I study of MK-1308 (anti–CTLA-4) plus pembrolizumab in previously treated advanced small cell lung cancer (Room B) - Oct 29, 2019 - Abstract #ESMOIO2019ESMO_IO_278;
P1
Funding: Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Clinical trial identification: NCT03179436.
- | 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.
Clinical trial identification: NCT03179436. 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.
- | 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.
Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. N=192 --> 288
- | Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Trial completion date, Trial primary completion date: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Feb 8, 2019
P1, N=308, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=192 --> 288 Trial completion date: Oct 2022 --> Mar 2023 | Trial primary completion date: Oct 2022 --> Mar 2023
- | Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Dec 19, 2018
P1, N=308, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Oct 2022 --> Mar 2023 | Trial primary completion date: Oct 2022 --> Mar 2023 Active, not recruiting --> Recruiting | N=168 --> 308 | Trial completion date: Sep 2020 --> Oct 2022 | Trial primary completion date: Sep 2020 --> Oct 2022
- | 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.
Active, not recruiting --> Recruiting | N=168 --> 308 | Trial completion date: Sep 2020 --> Oct 2022 | Trial primary completion date: Sep 2020 --> Oct 2022 Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD), quavonlimab (MK-1308) / Merck (MSD)
Enrollment closed: Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov) - Oct 1, 2018
P1, N=168, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || 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.
Recruiting --> Active, not recruiting Initiation date: Jul 2018 --> Dec 2018
- ||||| 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.