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Trial Title:
A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)
NCT ID:
NCT06460961
Condition:
Neoplasm Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Pembrolizumab
Conditions: Keywords:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
MK-6837
Description:
IV Infusion
Arm group label:
Arm 1: MK-6837 Monotherapy
Arm group label:
Arm 2: MK-6837 + Pembrolizumab Combination Therapy
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
IV Infusion
Arm group label:
Arm 2: MK-6837 + Pembrolizumab Combination Therapy
Other name:
MK-3475
Other name:
KEYTRUDA®
Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
and preliminary efficacy of MK-6837, administered as a monotherapy and in combination
with pembrolizumab (MK-3475), in participants with histologically or cytologically
confirmed advanced/metastatic solid tumors that have not responded to conventional
therapy. There will not be any hypothesis testing in the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed solid tumor by pathology report that is
advanced or metastatic
- Human Immunodeficiency Virus (HIV)-infected participants must have well controlled
HIV on Antiretroviral Therapy (ART)
- Participants who are Hepatitis B Surface Antigen (HBsAg) positive are eligible if
they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks,
and have undetectable HBV viral load before allocation
- Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV
viral load is undetectable at screening
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1
or better from any Adverse Events (AEs) that were due to cancer therapeutics
administered more than 4 weeks earlier
- History of a second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 2 years
- Has clinically significant cardiovascular disease
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric
Castleman's Disease
- Received prior systemic anticancer therapy including investigational agents within 4
weeks before the first dose of study intervention
- Has received any prior immunotherapy and was discontinued from that treatment due to
a Grade 3 or higher immune-related AE (except endocrine disorders that can be
treated with replacement therapy) or was discontinued from that treatment due to
Grade 2 myocarditis or recurrent Grade 2 pneumonitis
- Received prior radiotherapy within 2 weeks of start of study intervention, or has
radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines is allowed
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or
any other form of immunosuppressive therapy within 7 days before the first dose of
study intervention
- Known additional malignancy that is progressing or has required active treatment
within the past 2 years
- Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in the past 2 years
except replacement therapy
- History of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- History of allogeneic tissue/solid organ transplant
- Participants who have not adequately recovered from major surgery or have ongoing
surgical complications
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Atlantic Health System Morristown Medical Center ( Site 4001)
Address:
City:
Morristown
Zip:
07960
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
862-345-8666
Facility:
Name:
Providence Portland Medical Center ( Site 4002)
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
503-215-5696
Facility:
Name:
Westmead Hospital ( Site 1002)
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61403170371
Facility:
Name:
The Alfred Hospital ( Site 1001)
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61390763129
Facility:
Name:
Sheba Medical Center-ONCOLOGY ( Site 3001)
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97235307039
Start date:
July 14, 2024
Completion date:
July 13, 2029
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06460961
https://www.merckclinicaltrials.com/
