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-DE

Lead Sponsor: Clovis Oncology, Inc.

Brief Summary: Not available

Detailed Description: Not available

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 plasma or 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
NOTE: Bevacizumab is permitted in the first line and second line treatment (including maintenance) of advanced ovarian cancer as first line treatment of metastatic or recurrent cervical cancer in combination with chemotherapy (including maintenance), or as first-line and secondline treatment in combination with chemotherapy (including maintenance) or as single-agent for recurrent or metastatic endometrial cancer. An EMA- or FDA-approved biosimilar is an acceptable substitutefor bevacizumab.
• History of life-threatening toxicity related to prior immune therapy (eg, anti CTLA 4 or anti PD 1/PD L1 treatment or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hypothyroidism).

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<br>response (DOR), disease control rate (DCR), progression-free survival (PFS), and<br>overall survival (OS) by RECIST v1.1 by investigator;<br>• To characterize the PK profile of lucitanib when administered in combination with<br>nivolumab. <br>;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,<br> progression-free survival, overall survival.<br>3. Lucitanib PK parameters; AUC at steady state, Cmin, SS, Cmax, <br> SS, and CL/F<br>;Timepoint(s) of evaluation of this end point: 1. From first dose of study drug until disease progression (up to<br> approximately 2 years).<br>2. From first dose of study drug until at least 100 days after end of <br> treatment (up to approximately 2 years).<br>3. From first dose of study drug until the end of study (up to <br> approximately 2 years).<br>

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