A study to evaluate lucitanib in combination with nivolumab in patients with a solid tumor

Phase 1

• Conditions: Advanced gynecological solid tumor; MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002980-81-IT
• Lead Sponsor: CLOVIS ONCOLOGY, INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 161

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
• Availability of tumor tissue at screening
• ECOG performance status of 0 to 1
• Measurable disease (RECIST v1.1)
• Advanced, recurrent, or metastatic gynecological solid tumor
• Willing and able to provide an additional biopsy after 4 weeks of treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 97
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

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 (e.g.,
autoimmune hepatitis)
• Condition requiring systemic treatment with corticosteroids or
other immune suppressive medications
• Unstable or uncontrolled hypertension
(greater than 140/90 mmHg)
• Prior treatment with a VEGFR-tyrosine kinase inhibitor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Best Overall Response Rate (Phase 2).;Secondary Objective: • To evaluate the acute and long-term safety and tolerability of the combination;<br>• To further evaluate the preliminary efficacy of the combination in terms of duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) by RECIST v1.1 by investigator;<br>• To characterize the PK profile of lucitanib when administered in combination with nivolumab.;Primary end point(s): Confirmed best overall response (PR or CR) based on investigator assessment or objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.;Timepoint(s) of evaluation of this end point: From first dose of study drug until disease progression (up to approximately 2 years).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence of AEs, clinical lab abnormalities, and dose modifications.<br>2. Per RECIST v1.1: Duration of response, disease control, progression-free survival, overall survival.<br>3. Lucitanib PK parameters; AUC at steady state, Cmin, SS, Cmax, SS, and CL/F;Timepoint(s) of evaluation of this end point: 1. From first dose of study drug until disease progression (up to approximately 2 years).<br>2. From first dose of study drug until at least 100 days after end of treatment (up to approximately 2 years).<br>3. From first dose of study drug until the end of study (up to approximately 2 years).