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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Clovis Oncology, Inc.
Study ID
NCT04042116
Phase
PHASE1/PHASE2
Status
Suspended

Conditions

  • Advanced Solid Tumor
  • Gynecologic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lucitanib — DRUG
    Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
  • Lucitanib — DRUG
    Oral lucitanib will be administered once daily (QD). The dose will be 6 mg.
  • Lucitanib — DRUG
    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.
  • Nivolumab — DRUG
    IV nivolumab 480 mg will be administered once every 4 weeks.

Study Details

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)

Key Dates

Start date
Jul 29, 2019
Status verified
Dec 2022
Primary completion
Jul 31, 2023
Completion
Jan 31, 2024

Study Design

Enrollment
227 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Dose Escalation
    \- Up to 50 patients with advanced solid tumor
  • Experimental: Phase 1b: Food Effect Cohort
    \- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
  • Experimental: Phase 2: Expansion Cohort - Endometrial Cancer
    * Recurrent endometrial carcinoma at least 1 prior platinum-based chemotherapy regimen * Up to 10 patients who have progressed on treatment with 1 prior PD-(L)1 inhibitor administered as monotherapy will be allowed to enroll
  • Experimental: Phase 2: Expansion Cohort - Ovarian Cancer
    * Recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma * At least 2 prior chemotherapy regimens which at least 1 must have been platinum-doublet chemotherapy * Up to 10 subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma who have progressed within 6 months after completing first-line platinum-based chemotherapy will be allowed to enroll
  • Experimental: Phase 2: Expansion Cohort - Clear Cell Cancer
    * Recurrent, metastatic clear cell carcinoma of ovarian, fallopian tube, primary peritoneal or endometrial origin * At least 1 prior platinum- and taxane-based chemotherapy regimen
  • Experimental: Phase 2: Expansion Cohort - Cervical Cancer
    * Persistent or recurrent cervix cancer of squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma histology * At least 1 prior regimen of platinum-based chemotherapy, with or without bevacizumab, for metastatic disease

Primary Outcome Measure

Determine the recommended Phase 2 dose of the combination of lucitanib and nivolumab (Phase 1b) [ Time Frame: First dose of study drug through at least 100 days after end of treatment (up to approximately 2 years) ]

Locations (13)

FacilityCityStateZIPSite coordinators
UCLA Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-
UC San Diego Moores Cancer CenterSan DiegoCalifornia92093-
Anschutz Cancer PavilionAuroraColorado80045-
Florida Cancer SpecialistsSarasotaFlorida34232-
Massachusetts General HospitalBostonMassachusetts02114-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU Langone Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-
Duke University School of MedicineDurhamNorth Carolina27710-
Ohio State University Wexner Medical CenterColumbusOhio43210-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
Magee-Womens Hospital of UPMCPittsburghPennsylvania15213-
Tennessee OncologyNashvilleTennessee37203-
Swedish Cancer InstituteSeattleWashington98107-

Find similar trials in Los Angeles, CA

By research site
UCLA Jonsson Comprehensive Cancer Center· Los Angeles, CAUC San Diego Moores Cancer Center· San Diego, CAAnschutz Cancer Pavilion· Aurora, COFlorida Cancer Specialists· Sarasota, FLMassachusetts General Hospital· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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