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Monoclonal Antibodies
Combination Therapy for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Anna Spreafico
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be >= 18 years of age
Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic or unresectable or recurrent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30-37 days post treatment
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of anetumab ravtansine when given with nivolumab, ipilimumab, and gemcitabine hydrochloride to treat patients with mesothelin positive pancreatic cancer.
Who is the study for?
This trial is for adults with advanced pancreatic cancer that has spread and can't be removed by surgery. Participants must have tried at least one treatment before, have tumors expressing a protein called mesothelin, and be in good physical condition (ECOG score 0-1). They should not have untreated brain metastases or certain infections like HIV or hepatitis B/C. Women who can bear children and men with partners of childbearing potential must use effective contraception.Check my eligibility
What is being tested?
The study tests anetumab ravtansine combined with nivolumab, ipilimumab, or gemcitabine to see which works best against pancreatic cancer. Anetumab ravtansine targets cancer cells directly while the other drugs help the immune system fight the disease or stop tumor growth. The trial aims to find out the safest doses and how well these combinations work together.See study design
What are the potential side effects?
Possible side effects include reactions where the drug enters the body, organ inflammation due to immune response, fatigue, digestive issues like nausea or diarrhea, blood-related problems such as low counts of different cell types increasing infection risk. Each patient's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My pancreatic cancer has spread, cannot be removed by surgery, or has come back.
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I have tried at least one systemic therapy and it didn't work or I couldn't tolerate it.
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I have at least one tumor that can be measured on a CT or MRI scan.
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I am fully active or have minor restrictions in physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30-37 days post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30-37 days post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Biomarker analysis
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm III (anetumab ravtansine, nivolumab, gemcitabine)Experimental Treatment5 Interventions
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.
Group II: Arm II (anetumab ravtansine, nivolumab, ipilimumab)Experimental Treatment5 Interventions
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.
Group III: Arm I (anetumab ravtansine, nivolumab)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,593 Total Patients Enrolled
Anna SpreaficoPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
3 Previous Clinical Trials
243 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your albumin levels in the blood need to be at least 2.5 mg/dL or higher.Your hemoglobin level is 9 grams per deciliter or higher.I have not had major surgery in the last 4 weeks.My cancer has grown in an area previously treated with radiation, and the growth can be measured.I have a corneal condition or other eye issues as diagnosed by my eye doctor.Your absolute neutrophil count is at least 1,500 per microliter.I am currently receiving or have received chemotherapy or biological therapy.I am 18 years old or older.Your white blood cell count is at least 3,000 per microliter.I haven't taken strong immune system suppressing drugs recently, except for low-dose steroids or local treatments.My pancreatic cancer has spread, cannot be removed by surgery, or has come back.I am using or willing to use effective birth control during and 6 months after treatment. I understand the risk of infertility.I have tried at least one systemic therapy and it didn't work or I couldn't tolerate it.You are expected to live for at least 3 more months.I have had an organ transplant.I am currently undergoing or have completed radiation therapy.I have or had inflammatory bowel disease like ulcerative colitis.I haven't had a blood transfusion in the last 2 weeks.I have stable brain metastases and haven't used steroids in the last 14 days.My tumor shows positive for mesothelin based on specific testing.I haven't had any cancer other than skin or in situ bladder, breast, or cervical cancers in the last 3 years.I have had an autoimmune disease in the last 2 years.I've had cancer treatments before, but not with specific immune therapies, and any side effects are minimal.Your bilirubin levels are within the normal range for the hospital or clinic where you are being treated.My kidney function is within the safe range for the trial.I haven't had significant bleeding issues in the last month.I experience significant numbness, pain, or weakness in my hands or feet.Your AST and ALT levels in your blood should not be more than three times the normal limit set by the hospital.I am not currently on any treatments that are not allowed in this trial.I have not received any live vaccines in the last 30 days.I have recovered from major side effects of my last treatment.I do not have serious heart problems like uncontrolled high blood pressure or heart failure.I am not pregnant or breastfeeding and will avoid pregnancy during the study.I can provide samples of my tumor for testing.I can have a biopsy, and my cancer has a lesion that can be safely biopsied.I have HIV or hepatitis but it's under control.I have not taken strong medication inhibitors or inducers, or consumed grapefruit/juice that affects drug metabolism in the last 2 weeks.I have at least one tumor that can be measured on a CT or MRI scan.You have enough platelets in your blood (at least 100,000 per microliter).I am fully active or have minor restrictions in physical activity.I do not have an active infection needing IV drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (anetumab ravtansine, nivolumab)
- Group 2: Arm II (anetumab ravtansine, nivolumab, ipilimumab)
- Group 3: Arm III (anetumab ravtansine, nivolumab, gemcitabine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are numerous health care facilities in this state administering the research?
"At present, 38 clinical trial sites across the country are participating in this study. Notable locales include Lawrence, Salina and Irvine; it is suggested that patients pick a location closest to them so as to alleviate potential travel needs if they choose to join the experiment."
Answered by AI
What medical conditions is Anetumab Ravtansine typically used to treat?
"Anetumab Ravtansine is an effective therapeutic agent for treating malignant neoplasms, unresectable melanoma, as well as squamous cell carcinoma."
Answered by AI
Has Anetumab Ravtansine been studied in other research initiatives?
"Presently, Anetumab Ravtansine is the focus of 1186 active medical studies with 214 trials in the advanced Phase 3 stage. Pittsburgh, Pennsylvania has several clinical trials dedicated to this research but there are 62882 sites conducting such investigations worldwide."
Answered by AI
Are there any vacancies still available for participation in this experiment?
"According to the clinicaltrials.gov record, this medical experiment is actively recruiting patients with its inception on March 28th 2019 and most recently updated on November 24th 2022."
Answered by AI
What is the scope of individuals engaged in this investigation?
"Recruitment of 74 suitable participants is necessary to complete this trial, with multiple locations such as Lawrence Memorial Hospital in California and Salina Regional Health Center in Florida."
Answered by AI
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