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NCT05342636 Clinical Trial

A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)

Esophageal Squamous Cell Carcinoma (ESCC) Clinical Trial

Official title:
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05342636
Other study ID # 3475-06A
Secondary ID 20312201972021-0
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 27, 2022
Est. completion date September 21, 2026

Study information
Verified date May 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previously exposed to programmed cell death 1 protein (PD-1)/ programmed cell death ligand 1 (PD-L1) based treatment. With protocol amendment 5 (effective: 17-November-2023), enrollment in study arms "Pembrolizumab plus MK-4830 plus Chemotherapy" and "Pembrolizumab plus MK-4830 plus lenvatinib" is discontinued.

Description:

The master protocol is MK-3475-U06.

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Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Pembrolizumab
200 mg administered via intravenous (IV) infusion every 3 weeks (Q3W)
• Coformulation favezelimab/pembrolizumab
800 mg favezelimab + 200 mg pembrolizumab administered via IV infusion on day 1 and then Q3W
• MK-4830
800 mg administered via IV infusion Q3W
Drug:
• Lenvatinib
20 mg administered via oral capsules each day
• Irinotecan
180 mg/m^2 administered via IV infusion on day 1 of every 14-day cycle.
• Paclitaxel
80-100 mg/m^2 administered via IV infusion on Days 1, 8 and 15 of every 28 day cycle
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Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

Brazil,  Chile,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Norway,  Singapore,  Switzerland,  Taiwan,  Thailand,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing a Dose-limiting Toxicity (DLT) During Safety Lead-in Phase A DLT is defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. Up to approximately 3 weeks
Primary Number of Participants Experiencing an Adverse Event (AE) During Safety Lead-in Phase An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Up to approximately 3 Weeks
Primary Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Up to approximately 3 weeks
Primary Objective Response Rate (ORR) ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. Up to approximately 119 weeks
Secondary Progression-Free Survival (PFS) PFS is defined as the time from allocation to the first documented progressive disease (PD) as assessed by RECIST 1.1 or death due to any cause, whichever occurs first. PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. Up to approximately 216 weeks
Secondary Duration of Response (DOR) For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. Up to approximately 216 weeks
Secondary Overall Survival (OS) OS is defined as the time from the date of allocation to death from any cause. Up to approximately 216 weeks
Secondary Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Up to approximately 216 weeks
Secondary Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Up to approximately 104 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06078657 - IBI110 Combined With Sintilimab in Second-line Advanced or Metastatic Esophageal Squamous Cell Carcinoma(ESCC) Phase 2
Active, not recruiting NCT03708328 - A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT03957590 - Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC Phase 3
Completed NCT03430843 - A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma Phase 3
Active, not recruiting NCT04210115 - Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) Phase 3
Not yet recruiting NCT05473156 - A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies Phase 1/Phase 2
Active, not recruiting NCT03783442 - A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma Phase 3
Enrolling by invitation NCT04839471 - BI-754091 and Afatinib for Refractory Esophageal Squamous Cell Carcinoma (BEAR Study) Phase 2

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