NCT03906071

Brief Summary

This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
577

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2019

Longer than P75 for phase_3

Geographic Reach
12 countries

261 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 25, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

3.7 years

First QC Date

April 4, 2019

Results QC Date

March 19, 2024

Last Update Submit

October 16, 2025

Conditions

Keywords

SitravatinibNivolumabDocetaxelCheckpoint inhibitorMGCD516NSCLCSAPPHIRE

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    OS is defined as time from date of randomization to date of death due to any cause. Patients who did not die on study are censored at the date of the last on-study follow-up that the patient was known to be alive (including follow-up data). Results obtained via Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method.

    From randomization date to date of death due to any cause (Up to approximately 44 months)

Secondary Outcomes (13)

  • Number of Participants With Treatment-Emergent Adverse Event (TEAEs)

    From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 38 months)

  • Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation

    From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 38 months)

  • Number of Participants With Maximum Post Baseline Hematology Grade Results

    From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months)

  • Number of Participants With Maximum Post Baseline Chemistry Grade Results

    From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months)

  • Objective Response Rate (ORR) Per Central Radiographic Assessment

    From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 44 months)

  • +8 more secondary outcomes

Study Arms (2)

Nivolumab and Sitravatinib

EXPERIMENTAL

Nivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally, once daily.

Biological: NivolumabDrug: Sitravatinib

Docetaxel

ACTIVE COMPARATOR

Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.

Drug: Docetaxel

Interventions

NivolumabBIOLOGICAL

Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.

Also known as: Opdivo
Nivolumab and Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

Also known as: MGCD516
Nivolumab and Sitravatinib

Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.

Also known as: Taxotere
Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
  • Receipt of at least one but not more than two prior treatment regimens in the advanced setting
  • Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)
  • Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
  • Candidate to receive docetaxel as second or third line therapy

You may not qualify if:

  • Uncontrolled brain metastases
  • Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
  • Unacceptable toxicity with prior checkpoint inhibitor therapy
  • Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
  • Impaired heart function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (261)

Local Institution - 005-164

Birmingham, Alabama, 35243, United States

Location

Clearview Cancer Institute - Huntsville

Huntsville, Alabama, 35805, United States

Location

Palo Verde Cancer Specialists - Glendale

Glendale, Arizona, 85304, United States

Location

The Oncology Institute of Hope & Innovation - Tucson

Tucson, Arizona, 85745, United States

Location

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

Local Institution - 005-174

Jonesboro, Arkansas, 72401, United States

Location

NEA Baptist Fowler Family Center for Cancer Care

Jonesboro, Arkansas, 72401, United States

Location

Highlands Oncology Group - Springdale

Springdale, Arkansas, 72762, United States

Location

Comprehensive Blood and Cancer Center - Bakersfield

Bakersfield, California, 93309, United States

Location

Local Institution - 005-118

Beverly Hills, California, 90211, United States

Location

Local Institution - 005-171

Fresno, California, 93720, United States

Location

Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton

Fullerton, California, 92835, United States

Location

Local Institution - 005-096

Long Beach, California, 90813, United States

Location

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

Location

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, 90017, United States

Location

Local Institution - 005-185

Los Angeles, California, 90095, United States

Location

Local Institution - 005-072

Newport Beach, California, 92663, United States

Location

Local Institution - 005-109

Northridge, California, 91325, United States

Location

Local Institution - 005-177

Redlands, California, 92373, United States

Location

Local Institution - 005-112

Riverside, California, 92501, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Local Institution - 005-176

San Marcos, California, 92069, United States

Location

Local Institution - 005-192

Torrance, California, 90505, United States

Location

Local Institution - 005-090

West Covina, California, 91790, United States

Location

Local Institution - 005-105

Whittier, California, 90602, United States

Location

Local Institution - 005-097

Lafayette, Colorado, 80026, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Michael and Dianne Bienes Comprehensive Cancer Center

Fort Lauderdale, Florida, 33308, United States

Location

Local Institution - 005-120

Fort Myers, Florida, 33901, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Watson Clinic Cancer and Research Center

Lakeland, Florida, 33805, United States

Location

Mount Sinai Health System

Miami Beach, Florida, 33140, United States

Location

Local Institution - 005-120E

Naples, Florida, 34102, United States

Location

Local Institution - 005-079

Ocala, Florida, 34474, United States

Location

Local Institution - 005-104

Orlando, Florida, 32804, United States

Location

SCRI - Florida Cancer Specialists - North Region Research Office

St. Petersburg, Florida, 33705, United States

Location

SCRI - Florida Cancer Specialists - Panhandle Research Office

Tallahassee, Florida, 32308, United States

Location

Local Institution - 005-154

West Palm Beach, Florida, 33401, United States

Location

University Cancer & Blood Center (UCBC) - Athens

Athens, Georgia, 30607, United States

Location

Local Institution - 005-146

Atlanta, Georgia, 30318, United States

Location

John B. Amos Cancer Center Research

Columbus, Georgia, 31904, United States

Location

Local Institution - 005-119

Marietta, Georgia, 30060, United States

Location

Straub Medical Center

Honolulu, Hawaii, 96813, United States

Location

Local Institution - 005-191

Coeur d'Alene, Idaho, 83814, United States

Location

Local Institution - 005-151

Chicago, Illinois, 60625-3645, United States

Location

Local Institution - 005-110

Evanston, Illinois, 60201, United States

Location

Local Institution - 005-198

Niles, Illinois, 60714, United States

Location

Orchard Healthcare Research

Skokie, Illinois, 60077, United States

Location

Healthcare Research Network - Tinley Park

Tinley Park, Illinois, 60487, United States

Location

Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office

Fort Wayne, Indiana, 46804, United States

Location

Local Institution - 005-122

Goshen, Indiana, 46526, United States

Location

Franciscan Health Cancer Center Indianapolis

Indianapolis, Indiana, 46237, United States

Location

Local Institution - 005-150

Lafayette, Indiana, 47904, United States

Location

Local Institution - 005-169

Westwood, Kansas, 66205, United States

Location

Local Institution - 005-098

Wichita, Kansas, 67214, United States

Location

Commonwealth Cancer Center - Frankfort

Danville, Kentucky, 40422, United States

Location

Local Institution - 005-153

Louisville, Kentucky, 40241, United States

Location

New England Cancer Specialists - Scarborough

Scarborough, Maine, 04074, United States

Location

Local Institution - 005-178

Rockville, Maryland, 20850-6535, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Local Institution - 005-127

Minneapolis, Minnesota, 55404, United States

Location

Local Institution - 005-159

Saint Louis Park, Minnesota, 55426-5000, United States

Location

Jackson Oncology Associates - The Hederman Cancer Center

Jackson, Mississippi, 39202, United States

Location

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

Location

Kansas City Care Health Center - Research Medical Campus

Kansas City, Missouri, 64132, United States

Location

Sisters of Charity of Leavenworth Health St. Marys

Billings, Montana, 59102, United States

Location

Saint Francis Cancer Treatment Center

Grand Island, Nebraska, 68803, United States

Location

Methodist Hospital - Omaha

Omaha, Nebraska, 68114, United States

Location

The Oncology Institute of Hope & Innovation - Henderson

Henderson, Nevada, 89052, United States

Location

Local Institution - 005-152

Henderson, Nevada, 89074, United States

Location

Local Institution - 005-142

Florham Park, New Jersey, 07932, United States

Location

Local Institution - 005-163

Little Silver, New Jersey, 07739, United States

Location

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Regional Cancer Care Associates - Sparta

Sparta, New Jersey, 07871, United States

Location

Local Institution - 005-123

Johnson City, New York, 13790, United States

Location

Local Institution - 005-182

Lake Success, New York, 11042, United States

Location

New York Cancer & Blood Specialists - Port Jefferson Medical Oncology

Port Jefferson Station, New York, 11776, United States

Location

Local Institution - 005-107

Stony Brook, New York, 11794, United States

Location

Local Institution - 005-196

Canton, Ohio, 44708, United States

Location

USOR - Oncology Hematology Care - Blue Ash

Cincinnati, Ohio, 45242, United States

Location

Local Institution - 005-181

Columbus, Ohio, 43210, United States

Location

Tricounty Hematology and Oncology - Massillon

Massillon, Ohio, 44646, United States

Location

Local Institution - 005-103

Toledo, Ohio, 43623, United States

Location

Local Institution - 005-088

Oklahoma City, Oklahoma, 73120, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Local Institution - 005-073

Portland, Oregon, 97239, United States

Location

USOR - Alliance Cancer Specialists - Horsham (Abington Hematology Oncology Associates)

Horsham, Pennsylvania, 19044, United States

Location

Local Institution - 005-186

Philadelphia, Pennsylvania, 19111, United States

Location

Local Institution - 005-137A

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137B

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137C

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137D

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137E

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137F

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137G

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137H

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137I

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137J

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137K

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137L

Dickson, Tennessee, 37055, United States

Location

Local Institution - 005-137M

Hendersonville, Tennessee, 37075, United States

Location

Local Institution - 005-195

Memphis, Tennessee, 38120, United States

Location

Local Institution - 005-137

Nashville, Tennessee, 37203, United States

Location

Local Institution - 005-134

Austin, Texas, 78745, United States

Location

Local Institution - 005-075

Beaumont, Texas, 77702, United States

Location

Local Institution - 005-128

Dallas, Texas, 75203, United States

Location

Local Institution - 005-129

Dallas, Texas, 75231, United States

Location

Local Institution - 005-126

Dallas, Texas, 75246, United States

Location

USOR - Texas Oncology Northeast Texas - Denison

Denison, Texas, 75020, United States

Location

Local Institution - 005-124

Denton, Texas, 76201, United States

Location

The Center for Cancer & Blood Disorders - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Oncology Consultants - Texas Medical Center

Houston, Texas, 77030, United States

Location

Local Institution - 005-076

Houston, Texas, 77070, United States

Location

Millennium Research and Clinical Development

Houston, Texas, 77090, United States

Location

USOR - US Oncology Investigational Products Center

Irving, Texas, 75063, United States

Location

Local Institution - 005-125

McKinney, Texas, 75071, United States

Location

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, 78240, United States

Location

USOR - Texas Oncology - Sugar Land

Sugar Land, Texas, 77479, United States

Location

USOR - Texas Oncology Northeast Texas - Cancer and Research Institute - Tyler

Tyler, Texas, 75702, United States

Location

Local Institution - 005-144

Charlottesville, Virginia, 22903, United States

Location

Hematology Oncology Associates of Fredericksburg

Fredericksburg, Virginia, 24408, United States

Location

Virginia Cancer Institute - West End

Richmond, Virginia, 23229, United States

Location

Overlake Medical Center and Clinics

Bellevue, Washington, 98004, United States

Location

Local Institution - 005-082

Everett, Washington, 98201, United States

Location

Local Institution - 005-111

Seattle, Washington, 98109--1023, United States

Location

Local Institution - 005-187

Spokane, Washington, 99218, United States

Location

Local Institution - 005-081

Tacoma, Washington, 98405, United States

Location

Northwest Medical Specialties - Tacoma

Tacoma, Washington, 98405, United States

Location

Local Institution - 005-136

Vancouver, Washington, 98684, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

Local Institution - 005-116

Madison, Wisconsin, 53792, United States

Location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 005-201

Brasschaat, 2930, Belgium

Location

Local Institution - 005-200

Charleroi, 6000, Belgium

Location

Local Institution - 005-206

Edegem, 2650, Belgium

Location

Local Institution - 005-202

Ghent, 9000, Belgium

Location

Local Institution - 005-207

Ghent, 9000, Belgium

Location

Local Institution - 005-205

Roeselare, 8800, Belgium

Location

Local Institution - 005-204

Ronse, 9600, Belgium

Location

Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

Yvoir, B-5530, Belgium

Location

Local Institution - 005-259

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution - 005-250

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Local Institution - 005-252

Hamilton, Ontario, L8V 5C2, Canada

Location

Local Institution - 005-251

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 005-257

Windsor, Ontario, N8W 2X3, Canada

Location

Local Institution - 005-255

Montreal, Quebec, H3A 0G4, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Local Institution - 005-258

Québec, G1V 4G5, Canada

Location

Local Institution - 005-307

Brest, 29200, France

Location

Local Institution - 005-310

Bron, 69500, France

Location

Local Institution - 005-311

Créteil, 94000, France

Location

Local Institution - 005-303

Dijon, 21079, France

Location

Local Institution - 005-309

Le Mans, 72037, France

Location

Local Institution - 005-308

Limoges, 87042, France

Location

Local Institution - 005-317

Lyon, 69008, France

Location

Local Institution - 005-301

Marseille, 13009, France

Location

Local Institution - 005-312

Marseille, 13015, France

Location

Local Institution - 005-313

Montpellier, 34298, France

Location

Local Institution - 005-306

Mulhouse, 68100, France

Location

Local Institution - 005-302

Paris, 75018, France

Location

Local Institution - 005-314

Rouen, 76031, France

Location

Local Institution - 005-316

Saint-Herblain, 44805, France

Location

Local Institution - 005-305

Strasbourg, 67200, France

Location

Local Institution - 005-304

Villejuif, 94805, France

Location

Local Institution - 005-400

Bad Berka, 99437, Germany

Location

Local Institution - 005-418

Berlin, 13125, Germany

Location

Local Institution - 005-401

Bonn, 53127, Germany

Location

Local Institution - 005-412

Cologne, 51109, Germany

Location

Local Institution - 005-419

Essen, 45136, Germany

Location

Local Institution - 005-406

Esslingen am Neckar, 73730, Germany

Location

Local Institution - 005-403

Gauting, 82131, Germany

Location

Local Institution - 005-417

Grohansdorf, 22927, Germany

Location

Local Institution - 005-408

Halle, 06120, Germany

Location

Local Institution - 005-411

Immenstadt im Allgäu, 87509, Germany

Location

Local Institution - 005-416

Kassel, 34125, Germany

Location

Local Institution - 005-410

Löwenstein, 74245, Germany

Location

Local Institution - 005-405

Lübeck, 23538, Germany

Location

Local Institution - 005-414

Mainz, 55131, Germany

Location

Local Institution - 005-413

München, 81675, Germany

Location

Local Institution - 005-402

München, 81925, Germany

Location

Local Institution - 005-454

Budapest, 1083, Hungary

Location

Local Institution - 005-457

Budapest, 1121, Hungary

Location

Local Institution - 005-455

Budapest, 1122, Hungary

Location

Local Institution - 005-453

Farkasgyepű, 8582, Hungary

Location

Local Institution - 005-452

Győr, 9023, Hungary

Location

Local Institution - 005-451

Szombathely, 9700, Hungary

Location

Local Institution - 005-450

Tatabánya, 2800, Hungary

Location

Local Institution - 005-456

Törökbálint, 2045, Hungary

Location

Local Institution - 005-500

Afula, 1834111, Israel

Location

Local Institution - 005-501

Beer Yaakov, 7030000, Israel

Location

Local Institution - 005-504

Beersheba, 84101, Israel

Location

Local Institution - 005-502

Holon, 5822012, Israel

Location

Local Institution - 005-507

Jerusalem, 9103102, Israel

Location

Local Institution - 005-506

Ramat Gan, 5265601, Israel

Location

Local Institution - 005-505

Zsfat, 1311001, Israel

Location

Local Institution - 005-612

Alessandria, 15121, Italy

Location

Local Institution - 005-602

Bari, 70124, Italy

Location

Local Institution - 005-603

Catania, 95123, Italy

Location

Local Institution - 005-611

Cremona, 26100, Italy

Location

Local Institution - 005-608

Lecce, 73100, Italy

Location

Local Institution - 005-610

Meldola, 47014, Italy

Location

Local Institution - 005-606

Milan, 20141, Italy

Location

Local Institution - 005-605

Monza, 20900, Italy

Location

Local Institution - 005-604

Napoli, 80131, Italy

Location

Local Institution - 005-600

Parma, 43126, Italy

Location

Local Institution - 005-607

Piacenza, 29100, Italy

Location

Local Institution - 005-609

Pisa, 56126, Italy

Location

Local Institution - 005-614

Roma, 00144, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Local Institution - 005-700

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Local Institution - 005-703

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 005-711

Amsterdam, 1081 HV, Netherlands

Location

Local Institution - 005-707

Breda, 4818 CK, Netherlands

Location

Local Institution - 005-713

Dordrecht, 3318 AT, Netherlands

Location

Local Institution - 005-702

Groningen, 9728 NT, Netherlands

Location

Local Institution - 005-712

Maastricht, 6229 HX, Netherlands

Location

Local Institution - 005-714

Nijmegen, 6525 GA, Netherlands

Location

Local Institution - 005-710

Rotterdam, 3015 GD, Netherlands

Location

Local Institution - 005-705

Rotterdam, 3045 PM, Netherlands

Location

Local Institution - 005-709

The Hague, 2545 AA, Netherlands

Location

Local Institution - 005-701

Utrecht, 3543 AZ, Netherlands

Location

Local Institution - 005-708

Utrecht, 3584 CX, Netherlands

Location

Local Institution - 005-706

Zwolle, 8025 AB, Netherlands

Location

Local Institution - 005-807

A Coruña, 15006, Spain

Location

Local Institution - 005-800

Badalona, 08916, Spain

Location

Local Institution - 005-822

Barcelona, 08003, Spain

Location

Local Institution - 005-811

Barcelona, 08028, Spain

Location

Local Institution - 005-810

Barcelona, 08035, Spain

Location

Local Institution - 005-805

Jaén, 23007, Spain

Location

Local Institution - 005-816

Las Palmas de Gran Canaria, 35016, Spain

Location

Local Institution - 005-817

León, 24071, Spain

Location

Local Institution - 005-812

Lugo, 27003, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Local Institution - 005-808

Madrid, 28006, Spain

Location

Local Institution - 005-819

Madrid, 28027, Spain

Location

Local Institution - 005-821

Madrid, 28034, Spain

Location

Local Institution - 005-813

Madrid, 28040, Spain

Location

Local Institution - 005-815

Madrid, 28040, Spain

Location

Local Institution - 005-809

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Local Institution - 005-806

Majadahonda, 28222, Spain

Location

Local Institution - 005-801

Málaga, 29009, Spain

Location

Local Institution - 005-803

Oviedo, 33011, Spain

Location

Local Institution - 005-823

Santiago de Compostela, 15706, Spain

Location

IVO - Fundacion Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Local Institution - 005-804

Valencia, 46026, Spain

Location

Local Institution - 005-818

Vigo, 36312, Spain

Location

Inselspital Universitatsspital Bern

Bern, 3010, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 1205, Switzerland

Location

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, 1011, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Velindre University NHS Trust

Cardiff, CF14 2TL, United Kingdom

Location

Local Institution - 005-904

Cornwall, TR1 3LJ, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

Local Institution - 005-908

London, NW3 2QG, United Kingdom

Location

Local Institution - 005-900

London, SW3 6JJ, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Local Institution - 005-903

Middlesex, HA6 2RN, United Kingdom

Location

Related Links

MeSH Terms

Interventions

NivolumabsitravatinibDocetaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Limitations and Caveats

Participants enrolled in the USA who began treatment with the sitravatinib free base capsule formulation prior to protocol amendment 03 will remain on the free base capsule formulation throughout the duration of the study; the starting dose of sitravatinib free base capsule formulation was 120 mg QD.

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 8, 2019

Study Start

July 15, 2019

Primary Completion

March 20, 2023

Study Completion

September 30, 2025

Last Updated

October 21, 2025

Results First Posted

June 25, 2024

Record last verified: 2025-10

Locations