Pembrolizumab Plus Bevacizumab for Treatment of Brain Metastases in Metastatic Melanoma or Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT02681549
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab plus Bevacizumab — DRUG
    Pembrolizumab will be administered on day 1 of every cycle until disease progression or withdrawal from study. Bevacizumab will be administered in addition to pembrolizumab on day 1 of cycles 1, 2, 3, and 4 (or alternative cycles if bevacizumab is held during these cycles). Three weeks constitutes one cycle.

Study Details

The purpose of this phase 2 trial is to study the activity of pembrolizumab in combination with bevacizumab in patients with untreated brain metastases from melanoma or NSCLC to determine activity and safety of the drug combination. Furthermore, in patients who undergo resection of biopsy of a brain metastasis, we will evaluate biomarkers predictive of treatment benefit, and will also conduct correlative biomarker studies on extra-cerebral specimens in all patients in whom a systemic biopsy is feasible or in archival tumor tissue when available. A total of 53 eligible patients will be enrolled on this trial (40 with melanoma and 13 with NSCLC). Individual cohorts of the study can be stopped if insufficient activity is observed in the first stage of that cohort. The study will accrue for approximately 84 months, and will be open for approximately 12 additional months as patients on study are being followed.

Key Dates

First listed
Feb 12, 2016
Start date
May 1, 2016
Status verified
Jul 2025
Primary completion
Sep 11, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Untreated brain metastases from melanoma
    pembrolizumab plus bevacizumab
  • Experimental: Untreated brain metastases from NSCLC
    pembrolizumab plus bevacizumab

Primary Outcome Measure

Brain Metastasis Response Rate (BMRR) [ Time Frame: up to 2 years from start of treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Smilow Cancer Hospital at Yale New HavenNew HavenConnecticut06510-
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in New Haven, CT

By condition
MelanomaLung cancer
By specialty
OncologySkin cancerDermatologyLung oncologyLung disease
By research site
Smilow Cancer Hospital at Yale New Haven· New Haven, CTMoffitt Cancer Center· Tampa, FL

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