Advanced gynecological solid tumor MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864
Conditions
Sponsors
Clovis Oncology, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 substitute for 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).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of AEs, clinical lab abnormalities, and dose modifications. 2. Per RECIST v1.1: Duration of response, disease control, progression-free survival, overall survival. 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). 2. From first dose of study drug until at least 100 days after end of treatment (up to approximately 2 years). 3. From first dose of study drug until the end of study (up to approximately 2 years). | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Best Overall Response Rate (Phase 2).;Secondary Objective: • To evaluate the acute and long-term safety and tolerability of the combination; • 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; • 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). | — |
Countries
Austria, Belgium, Germany, Italy, Spain, United States
Contacts
Public ContactChief Medical Officer
Clovis Oncology UK Limited
Outcome results
None listed