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Carboplatin/Nab-Paclitaxel and Pembrolizumab in NSCLC

NCT02382406 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-05-23

Study results available
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Summary

This is a phase I/II study for previously untreated subjects with advanced NSCLC. The study will take place in two phases. First, a cohort of twelve participants will be enrolled in phase I part and will be treated with carboplatin, nab-paclitaxel and pembrolizumab. A cohort of twelve subjects will be evaluated for safety and tolerability after 2 cycles of therapy. All subjects who receive either nab-paclitaxel or pembrolizumab will be evaluable. If 33% of subjects or less have unacceptable toxicity in the first cohort or any subsequent cohort (if necessary), the study will proceed to the Phase II part. If more than 33% have unacceptable toxicity, 12 additional subjects will be enrolled in a second cohort, if necessary. If unacceptable toxicity is seen in more than 33% in Cohort 2, the study will end due to unacceptable toxicity of this drug combination.

The phase II part of the study is a single arm study. All subjects will be treated with carboplatin, nab-paclitaxel, and pembrolizumab in 21-day cycles for up to 4 cycles.

Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for all subjects (only if adequate archived samples are unavailable). Mandatory tumor biopsies will be obtained in the Phase II part of the study after 4 cycles of study treatment or at the time of progression, whichever comes first.

For subjects without progression of disease after Cycle 4, pembrolizumab will continue every 3 weeks for up to 2 years or until unacceptable toxicity.

Conditions

Interventions

DRUG

Carboplatin

Carboplatin AUC 6 IV, D1 for 4 cycles (cycle = 21 days)

DRUG

Nab-paclitaxel

Nab-paclitaxel 100 mg/m2 IV, D1, D8, D15 for 4 cycles (cycle = 21 days)

DRUG

MK-3475 (Phase I)

MK-3475 2 mg/kg IV, D1 for 4 cycles (Cohort 1) or 3 cycles (Cohort 2) (cycle = 21 days) Maintenance MK-3475 2 mg/kg IV continues every 21 days after Cycle 4 for up to 2 years.

DRUG

MK-3475 (Phase II)

MK-3475 200 mg IV Day 1 of each cycle (cycle = 21 days) Maintenance MK-3475 2 mg/kg IV continues every 21 days after Cycle 4 for up to 2 years.

Sponsors & Collaborators

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • Nisha Mohindra, MD

    lead OTHER

Principal Investigators

  • Nisha Mohindra, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-04
Primary Completion
2022-04-14
Completion
2022-04-14

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02382406 on ClinicalTrials.gov