ClinicalTrials.Veeva

Menu

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

C

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)

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

Trial contacts and locations

27

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems