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

Clovis Oncology, Inc.227 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

227

Conditions

Advanced Solid Tumor Gynecologic Cancer

Interventions

LucitanibDRUG

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

LucitanibDRUG

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

LucitanibDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

General Inclusion Criteria: * ≥ 18 years of age * Adequate organ function * Life expectancy ≥ 3 months * Women of childbearing potential must have a negative serum pregnancy test * Advanced/metastatic solid tumor (Phase 1b) * Availability of tumor tissue at screening * ECOG performance status of 0 to 1 * Measurable disease (RECIST v1.1) (Phase 2) * Advanced, recurrent, or metastatic gynecological solid tumor (Phase 2) * Willing and able to fast, and to eat a high-fat breakfast (Food Effect) General Exclusion Criteria: * Prior treatment with lucitanib * Active second malignancy * Active central nervous system brain metastases * Pre-existing duodenal stent or any gastrointestinal disorder * Known history of HIV or AIDs; positive result of hepatitis B or C viruses * Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis * Active, known or suspected autoimmune disease (eg, autoimmune hepatitis) * Condition requiring systemic treatment with corticosteroids or other immune suppressive medications * Unstable or uncontrolled hypertension (BP ≥ 140/90 mmHg) * Prior treatment with a VEGFR-tyrosine kinase inhibitor (Phase 2)

Locations (27)

Outcomes

Primary Outcomes

Determine the recommended Phase 2 dose of the combination of lucitanib and nivolumab (Phase 1b)

Incidence of adverse events and clinical lab abnormalities defined as dose-limiting toxicities and maximum tolerated dose.

Time frame: First dose of study drug through at least 100 days after end of treatment (up to approximately 2 years)

Best Overall Response Rate (Phase 2)

Confirmed best overall response (PR or CR) based on investigator assessment of objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Time frame: From first dose of study drug until disease progression (up to approximately 2 years)

Secondary Outcomes

Acute and long-term safety and tolerability of the combination (Phase 2)

Incidence of AEs, clinical lab abnormalities, and dose modifications.

Time frame: From first dose of study drug until disease progression (up to approximately 2 years)

Further evaluation of preliminary efficacy of combination (Phase 2)

Duration of response, progression-free survival, and disease control per RECIST v1.1, overall survival.

Time frame: From first dose of study drug until at least 100 days after end of treatment (up to approximately 2 years)

Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect]

Area under the curve \[AUCss\]

Time frame: From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)

Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect]

Maximum plasma concentration \[Cmax,ss\]

Time frame: From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)

Data from ClinicalTrials.gov

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