Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03816358
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Pancreatic Adenocarcinoma
  • Stage II Pancreatic Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Anetumab Ravtansine — BIOLOGICAL
    Given IV
  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the side effects and best dose of anetumab ravtansine when given together with nivolumab, ipilimumab and gemcitabine hydrochloride in treating patients with mesothelin positive pancreatic cancer that has spread to other places in the body (advanced). Anetumab ravtansine is a monoclonal antibody, called anetumab ravtansine, linked to a chemotherapy drug called DM4. Anetumab attaches to mesothelin positive cancer cells in a targeted way and delivers DM4 to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving anetumab ravtansine together with nivolumab, ipilimumab, and gemcitabine hydrochloride may work better in treating patients with pancreatic cancer.

Key Dates

Start date
Dec 9, 2019
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (anetumab ravtansine, nivolumab)
    Patients receive anetumab ravtansine IV over 1 hour on day 1 and nivolumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of subsequent cycles. Treatment repeats every 21 or 28 days (cycle 1) for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a biopsy and collection of blood on study.
  • Experimental: Arm II (anetumab ravtansine, nivolumab, ipilimumab)
    Patients receive anetumab ravtansine IV over 1 hour on day 1 and nivolumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of subsequent cycles. Patients also receive ipilimumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of cycles 2-4. Treatment repeats every 21 or 28 days (cycle 1) for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a biopsy and collection of blood on study.
  • Experimental: Arm III (anetumab ravtansine, nivolumab, gemcitabine)
    Patients receive anetumab ravtansine IV over 1 hour on day 1 and nivolumab IV over 30 minutes on day 8 of cycle 1 and on day 1 of subsequent cycles. Patients also receive gemcitabine hydrochloride over 30-40 minutes on days 1 and 8. Treatment repeats every 21 or 28 days (cycle 1) for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a biopsy and collection of blood on study.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to 30-37 days post treatment ]

Locations (44)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
City of Hope at Irvine LennarIrvineCalifornia92618-
Keck Medicine of USC KoreatownLos AngelesCalifornia90020-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCHealth University of Colorado HospitalAuroraColorado80045-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
Northwestern UniversityChicagoIllinois60611-
University of Kansas Clinical Research CenterFairwayKansas66205-
HaysMedHaysKansas67601-
University of Kansas Cancer CenterKansas CityKansas66160-
Lawrence Memorial HospitalLawrenceKansas66044-
The University of Kansas Cancer Center - OlatheOlatheKansas66061-
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210-
University of Kansas Hospital-Indian Creek CampusOverland ParkKansas66211-
Mercy Hospital PittsburgPittsburgKansas66762-
Salina Regional Health CenterSalinaKansas67401-
University of Kansas Health System Saint Francis CampusTopekaKansas66606-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Weisberg Cancer Treatment CenterFarmington HillsMichigan48334-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
University Health Truman Medical CenterKansas CityMissouri64108-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas CityMissouri64116-
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Birmingham, AL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALCity of Hope Comprehensive Cancer Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CAKeck Medicine of USC Koreatown· Los Angeles, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CA

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