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Spots Global Cancer Trial Database for Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer

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Trial Identification

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

Official Title: A Phase I Study of Anetumab Ravtansine in Combination With Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma

Study ID: NCT03816358

Study Description

Brief Summary: 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.

Detailed Description: PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of anetumab ravtansine with the following combinations in patients with mesothelin positive pancreatic adenocarcinoma. SECONDARY OBJECTIVES: I. To assess the preliminary anti-tumor activity of anetumab ravtansine (anetumab) in combination with nivolumab, nivolumab and ipilimumab, nivolumab and gemcitabine hydrochloride (gemcitabine) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR). II. To characterize the pharmacokinetics (PK) profile of anetumab (apparent diffusion coefficient \[ADC\]), total antibody (ADC and cleaved free antibody), DM4 and DM4-Me (S-Methyl metabolite of DM4). III. To evaluate the tumor microenvironment and immune changes in tumor and peripheral blood over the course of treatment to identify predictors of response or resistance to treatment. IV. To measure the progressive disease (PD) effects of this combination including molecular and immune biomarkers in tumor biopsies and peripheral blood. EXPLORATORY OBJECTIVES: I. To characterize mesothelin, PD-L1, CD3, CD4, CD8 expressions at baseline and after treatment in mesothelin positive pancreatic cancer patients. II. To evaluate level of soluble mesothelin and megakaryocyte potentiation factor (MPF) over the course of treatment and to correlate these biomarkers with clinical outcome. III. To perform whole exome sequencing (WES) +/- ribonucleic acid sequencing (RNAseq) in the tumor biopsy specimens and correlation genomic (e.g. mutational burden) and transcriptomic biomarkers with clinical outcome. IV. To evaluate mononuclear phagocyte system (MPS) function, Fc-gamma receptors (FcgammaRs) and hormone and chemokine mediators as methods to evaluate factors affecting the PK and PD of these agents. V. To evaluate anti-drug antibody (ADA) titres changes pre and post treatment and correlate them with PK, toxicity and responses. OUTLINE: This is a dose-escalation study of anetumab ravtansine. Patients are assigned to 1 of 3 arms. ARM I: Patients receive anetumab ravtansine intravenously (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. ARM II: 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. ARM III: 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. After completion of study treatment, patients are followed up every 8 weeks for up to 100 days, then every 12 weeks thereafter.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

City of Hope at Irvine Lennar, Irvine, California, United States

Keck Medicine of USC Koreatown, Los Angeles, California, United States

Los Angeles General Medical Center, Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

UCHealth University of Colorado Hospital, Aurora, Colorado, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States

Northwestern University, Chicago, Illinois, United States

University of Kansas Clinical Research Center, Fairway, Kansas, United States

HaysMed, Hays, Kansas, United States

University of Kansas Cancer Center, Kansas City, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Olathe Health Cancer Center, Olathe, Kansas, United States

University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States

University of Kansas Hospital-Indian Creek Campus, Overland Park, Kansas, United States

Ascension Via Christi - Pittsburg, Pittsburg, Kansas, United States

Salina Regional Health Center, Salina, Kansas, United States

University of Kansas Health System Saint Francis Campus, Topeka, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States

Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States

University Health Truman Medical Center, Kansas City, Missouri, United States

University of Kansas Cancer Center - North, Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States

University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Siteman Cancer Center-South County, Saint Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

M D Anderson Cancer Center, Houston, Texas, United States

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

Contact Details

Name: Anna Spreafico

Affiliation: University Health Network Princess Margaret Cancer Center LAO

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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