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A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

NCT04042116 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2022-12-20

No results posted yet for this study

Summary

This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed state (Food Effect)

Conditions

  • Advanced Solid Tumor
  • Gynecologic Cancer

Interventions

DRUG

Lucitanib

Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.

DRUG

Lucitanib

Oral lucitanib will be administered once daily (QD). The dose will be 6 mg.

DRUG

Lucitanib

Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg. Subjects will be allowed to intrapatient dose escalate in increments of 2 mg up to a total dose of 10 mg QD lucitanib if they meet the study specific clinical criteria.

DRUG

Nivolumab

IV nivolumab 480 mg will be administered once every 4 weeks.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Clovis Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Erika Hamilton, MD · Tennessee Oncology

  • Nicole Concin, MD · KEM Kliniken Essen Mitte Evang. Huyssens-Stiftung

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
2019-07-29
Primary Completion
2023-07-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT04042116 on ClinicalTrials.gov