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| ID | Type | Description | Link |
|---|---|---|---|
| ENGOT-GYN3/AGO/LIO | Other Identifier | ENGOT |
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Company decision
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b: Dose Escalation | Experimental | - Up to 50 patients with advanced solid tumor |
|
| Phase 1b: Food Effect Cohort | Experimental | - Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled |
|
| Phase 2: Expansion Cohort - Endometrial Cancer | Experimental |
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| Phase 2: Expansion Cohort - Ovarian Cancer | Experimental |
|
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| Phase 2: Expansion Cohort - Clear Cell Cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucitanib | Drug | Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the recommended Phase 2 dose of the combination of lucitanib and nivolumab (Phase 1b) | Incidence of adverse events and clinical lab abnormalities defined as dose-limiting toxicities and maximum tolerated dose. | First dose of study drug through at least 100 days after end of treatment (up to approximately 2 years) |
| Best Overall Response Rate (Phase 2) | Confirmed best overall response (PR or CR) based on investigator assessment of objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | From first dose of study drug until disease progression (up to approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and long-term safety and tolerability of the combination (Phase 2) | Incidence of AEs, clinical lab abnormalities, and dose modifications. | From first dose of study drug until disease progression (up to approximately 2 years) |
| Further evaluation of preliminary efficacy of combination (Phase 2) |
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General Inclusion Criteria:
General Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erika Hamilton, MD | Tennessee Oncology | Principal Investigator |
| Nicole Concin, MD | KEM Kliniken Essen Mitte Evang. Huyssens-Stiftung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States | ||
| UC San Diego Moores Cancer Center |
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.
Data will be provided by Clovis Oncology.
Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@clovisoncology.com.
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| Experimental |
|
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| Phase 2: Expansion Cohort - Cervical Cancer | Experimental |
|
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| Lucitanib | Drug | Oral lucitanib will be administered once daily (QD). The dose will be 6 mg. |
|
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| 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. |
|
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| Nivolumab | Drug | IV nivolumab 480 mg will be administered once every 4 weeks. |
|
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Duration of response, progression-free survival, and disease control per RECIST v1.1, overall survival. |
| From first dose of study drug until at least 100 days after end of treatment (up to approximately 2 years) |
| Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect] | Area under the curve [AUCss] | From first dose of study drug to the end of Cycle 1 (each cycle is 28 days) |
| Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect] | Maximum plasma concentration [Cmax,ss] | From first dose of study drug to the end of Cycle 1 (each cycle is 28 days) |
| Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect] | Total clearance of drug after oral administration [CLss/F] | From first dose of study drug to the end of Cycle 1 (each cycle is 28 days) |
| Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect, Phase 2] | Minimum plasma concentration [Cmin,ss] | From Cycle 2 to Cycle 5 (each cycle is 28 days) |
| Lucitanib PK Profile at single dose [Food Effect Cohort] | Area under the curve [AUC] | From first dose of study drug to Day -1 |
| Lucitanib PK Profile at single dose [Food Effect Cohort] | Maximum plasma concentration [Cmax] | From first dose of study drug to Day -1 |
| Lucitanib PK Profile at single dose [Food Effect Cohort] | Time to maximum plasma concentration [Tmax] | From first dose of study drug to Day -1 |
| The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort] | Area under the curve [AUC] | From first dose of study drug to Day -1 |
| The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort] | Maximum plasma concentration [Cmax] | From first dose of study drug to Day -1 |
| The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort] | Time to maximum plasma concentration [Tmax] | From first dose of study drug to Day -1 |
| San Diego |
| California |
| 92093 |
| United States |
| Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| NYU Langone Laura and Isaac Perlmutter Cancer Center | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27710 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98107 | United States |
| Medical University of Innsbruck | Innsbruck | 6020 | Austria |
| Saint Luc Univerisity Hospital | Brussels | 1200 | Belgium |
| University Hospital Ghent | Ghent | 9000 | Belgium |
| University Hospitals Leuven, Campus Gasthuisberg | Leuven | 3000 | Belgium |
| University Hospital Carl Gustav Carus | Dresden | 01307 | Germany |
| Kliniken Essen-Mitte | Essen | 45136 | Germany |
| University Hospital Mannhein | Mannheim | 68167 | Germany |
| Polyclinic S. Orsola-Malpighi | Bologna | 40138 | Italy |
| National Cancer Institute -IRCCS "Fondazione G. Pascale | Naples | 80131 | Italy |
| Foundation IRCCS Hospital Agostino Gemelli | Rome | 00168 | Italy |
| University Hospital Reina Sofia | Córdoba | Andalusia | 14004 | Spain |
| University Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Navarra University Clinic | Madrid | 28027 | Spain |
| La Paz University Hospital | Madrid | 28046 | Spain |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 25, 2023 | Jun 20, 2023 | 14 | ||
| Jun 26, 2023 | Jul 17, 2023 | 15 |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D002577 | Uterine Cervical Diseases |
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| ID | Term |
|---|---|
| C000595232 | E-3810 |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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