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

Clovis Oncology

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Advanced Solid Tumor; Gynecologic Cancer

Treatments: Drug: Nivolumab; Drug: Lucitanib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04042116

CO-3810-101

ENGOT-GYN3/AGO/LIO (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 227 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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227 participants in 6 patient groups

Phase 1b: Dose Escalation

Experimental group

Description:

- Up to 50 patients with advanced solid tumor

Treatment:

Drug: Nivolumab

Drug: Lucitanib

Drug: Lucitanib

Drug: Lucitanib

Phase 1b: Food Effect Cohort

Experimental group

Description:

- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled

Treatment:

Drug: Nivolumab

Drug: Lucitanib

Drug: Lucitanib

Drug: Lucitanib

Phase 2: Expansion Cohort - Endometrial Cancer

Experimental group

Description:

* 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

Treatment:

Drug: Nivolumab

Drug: Lucitanib

Drug: Lucitanib

Drug: Lucitanib

Phase 2: Expansion Cohort - Ovarian Cancer

Experimental group

Description:

* 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

Treatment:

Drug: Nivolumab

Drug: Lucitanib

Drug: Lucitanib

Drug: Lucitanib

Phase 2: Expansion Cohort - Clear Cell Cancer

Experimental group

Description:

* Recurrent, metastatic clear cell carcinoma of ovarian, fallopian tube, primary peritoneal or endometrial origin * At least 1 prior platinum- and taxane-based chemotherapy regimen

Treatment:

Drug: Nivolumab

Drug: Lucitanib

Drug: Lucitanib

Drug: Lucitanib

Phase 2: Expansion Cohort - Cervical Cancer

Experimental group

Description:

* 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

Treatment:

Drug: Nivolumab

Drug: Lucitanib

Drug: Lucitanib

Drug: Lucitanib