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Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)

An Open-Label, Phase II Study to Determine the Immunologic Correlates of Pembrolizumab-Mediated Tumor Regression in Subjects With Advanced Melanoma (KEYNOTE-161)

NCT03407170•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

In this study, participants with advanced melanoma will be treated with pembrolizumab (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab therapy. The primary hypotheses are that participants who respond to pembrolizumab have: 1. a higher fraction of cytotoxic tumor-infiltrating T-lymphocytes (FCT) at baseline compared to those who do not respond to pembrolizumab 2. a higher fold-increase in FCT compared to baseline than those who do not respond to pembrolizumab 3. a higher Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) compared to those who do not respond to pembrolizumab

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a histologically confirmed diagnosis of unresectable stage III or metastatic melanoma not amenable to local therapy
•Has testing for a BRAF mutation prior to study entry
•Has measurable disease per RECIST 1.1 as assessed by the investigator/radiology
•Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the participant received major surgery or radiation therapy of \>30 Gray units, they must have recovered from the toxicity and/or complications from the intervention
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days of study start
•A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and agrees to use a contraceptive method, consistent with local regulations regarding the methods of contraception for those participating in clinical studies, during the treatment period and for at least 120 days after the last dose of study treatment
•A male participant is eligible to participate if he agrees not to donate sperm PLUS to be abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, consistent with local regulations regarding the methods of contraception for those participating in clinical studies, during the treatment period and for at least 120 days after the last dose of study treatment

Exclusion Criteria

•Has disease that is suitable for local therapy administered with curative intent
•Has a history of interstitial lung disease
•Has a positive pregnancy test within 72 hours before the first dose of study therapy
•Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
•Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start
•Has received prior radiotherapy within 2 weeks of start of study therapy
•Has received a live vaccine within 30 days prior to the first dose of study therapy
•Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor \[G-CSF\], granulocyte macrophage colony stimulating factor \[GMCSF\] or recombinant erythropoietin) within 4 weeks prior to study start
•Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy
•Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy
+11 more criteria

Locations (2)

Massachusetts General Hospital ( Site 0102)

Boston, Massachusetts, United States

Dana Farber Cancer Institute ( Site 0101)

Boston, Massachusetts, United States

Key Dates

Start Date

June 28, 2018

Primary Completion Date

August 14, 2019

Completion Date

August 14, 2019

Last Updated

July 15, 2020

Enrollment

ACTUAL participants

Conditions

Advanced Melanoma

Interventions

pembrolizumab

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

A Phase II Trial of LM103 in Advanced Melanoma

FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis

HS-IT101 Injection in the Treatment of Advanced Melanoma