Monoclonal Antibodies
Anetumab Ravtansine for Pancreatic Cancer
UCHealth University of Colorado Hospital, Aurora, CO
Targeting 6 different conditionsAnetumab Ravtansine +5 morePhase 1Waitlist AvailableLed by Anna SpreaficoResearch Sponsored by National Cancer Institute (NCI)Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Life expectancy of at least 3 months
Note: Measurable lesions may be in an irradiated field as long as there is documented progression and the lesion(s) can be reproducibly measured
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 30-37 days post treatment
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
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.
Eligible Conditions
- Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are expected to live for at least 3 more months.
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If you have previously received radiation treatment in a specific area of your body, but the disease in that area has worsened and can be accurately measured, you may still be eligible for the study.
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You must have tried at least one type of treatment for your condition, but it did not work or caused negative side effects.
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You can have received chemotherapy, radiation therapy, hormonal therapy, or other cancer treatments in the past as long as any side effects have resolved or improved. However, if you have received specific immunotherapy drugs (anti-CTLA4, anti-PD1/PD-L1, or a combination of both), you will not be eligible.
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
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1120
Biospecimen Collection
2004
Completed Phase 1
~1250
Gemcitabine
FDA approved
Ipilimumab
FDA approved
Nivolumab
FDA approved
Find a site
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,402 Previous Clinical Trials
41,225,267 Total Patients Enrolled
Anna SpreaficoPrincipal Investigator
University Health Network Princess Margaret Cancer Center LAO3 Previous Clinical Trials
329 Total Patients Enrolled
Media Library
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