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A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer

NCT02960906 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-04-26

No results posted yet for this study

Summary

Disease and Stage: naïve metastatic kidney cancer.

A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer

Conditions

  • Clear Cell Metastatic Renal Cell Carcinoma

Interventions

DRUG

Nivolumab

For Arms 1A and 4A: Nivolumab alone administered IV over 60 minutes at 240 mg every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol. For Arms 1B, 2B, 3B and 4B: Nivolumab administered IV over 60 minutes at 3 mg/kg combined with ipilimumab administered IV over 30 minutes at 1 mg/kg every 3 weeks for 4 doses followed by nivolumab administered IV over 60 minutes at 240 mg every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol. Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference.

DRUG

Ipilimumab

For Arms 1B, 2B, 3B and 4B: Ipilimumab administered IV over 30 minutes at 1 mg/kg every 3 weeks combined with Nivolumab administered IV over 60 minutes at 3 mg/kg for 4 doses until disease progression, unacceptable toxicity or other reasons specified in the protocol.

DRUG

Pazopanib

For Arms 2C and 3C (TKI pazopanib or sunitinib): Pazopanib 800 mg orally QD until disease progression, unacceptable toxicity or other reasons specified in the protocol

DRUG

Sunitinib

For Arms 2C and 3C (TKI pazopanib or sunitinib): Sunitinib 50 mg orally QD until disease progression, unacceptable toxicity or other reasons specified in the protocol

Sponsors & Collaborators

  • Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

    lead OTHER

Principal Investigators

  • Yann-Alexandre VANO, MD · Hôpital Européen Georges Pompidou; Oncology department of Pr Stéphane OUDARD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2021-02-15
Completion
2021-02-15

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT02960906 on ClinicalTrials.gov