- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693846
Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
A Phase II Study of Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must have signed and dated an IRB-approved written informed consent form prior to the performance of any protocol-related procedures that are not part of standard care.
- Colorectal or appendiceal mucinous adenocarcinoma with peritoneal-only metastatic disease. It is recognized that in some patients, peritoneal disease will predominate without distinction of the site of origin, and such patients will be eligible.
- Microsatellite stable by PCR and/or mismatch repair proficient by immunohistochemistry
- ECOG performance status of 0 or 1
- Prior therapy with a fluoropyrimidine, oxaliplatin, and irinotecan unless contraindicated or refused. Prior treatment with antiangiogenic and/or anti-EGFR antibody therapy is permitted but not required
- Measurable disease by RECIST v. 1.1
Laboratory parameters:
- Absolute neutrophil count > 1500/μL
- Platelets > 100,000/μL
- Hemoglobin > 9.0 g/dL
- PT/INR or PTT < 1.5xULN
- Creatinine < 1.5xULN OR creatinine clearance > 50 mL/min by Cockcroft-Gault formula
- Total bilirubin < 1.5xULN
- Subjects with Gilbert's Syndrome must have a total bilirubin level of < 3.0xULN
- Albumin > 3.0 g/dL
- AST and/or ALT: < 3.0×ULN
Subjects with HIV are permitted provided they meet the following criteria:
- CD4+ cell count > 250 cells/mm3
- No history of AIDS-defining conditions other than low CD4+ count
- If subject is on antiretroviral therapy, there must not be expected significant drug-drug interactions with study treatment
Exclusion Criteria:
- Bowel obstruction within the past 60 days
Subjects who are currently pregnant, planning to become pregnant, or breast-feeding.
- Females participants of child-bearing potential are required to use an effective contraception method or abstain from intercourse during treatment and for at least 5 months following the last dose
- Males participants with partners of child-bearing potential are required to use an effective contraception method or abstain from intercourse during treatment and for at least 7 months following the last dose
- Subjects who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation
Subjects with contraindications to immune checkpoint therapy, as follows:
- Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
- Prior organ allograft or allogeneic bone marrow transplantation
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator
Condition requiring systemic treatment with corticosteroids
- Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted.
- Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted.
- Established non-peritoneal metastatic disease, including but not limited to metastases to the liver, lung, brain, extra-abdominal lymph nodes, and bone
- A second primary malignancy that, in the judgment of the investigator, may affect interpretation of results
- Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody
Toxicities attributed to prior anti-cancer therapy other than alopecia, fatigue, and peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug. In addition, a washout period will be required for prior therapies as specified:
- No chemotherapy within 14 days prior to first dose
- No investigational product(s) (IPs) and/or biologic therapy within 28 days or 5 half-lives, whichever is longer, prior to first dose
- No major surgery within 28 days prior to first dose. Any surgery-related AE(s) must have resolved at least 14 days prior to first dose.
- No radiation therapy with curative intent within 28 days prior to first dose. Prior focal palliative radiotherapy must have been completed at least 14 days prior to first dose.
Active hepatitis B or hepatitis C, defined as the following:
- Hepatitis B surface antigen positive or HBV DNA PCR >100 IU/mL
- Hepatitis C antibody positive unless HCV RNA PCR is negative (i.e. undetectable viral load)
- Prisoners or participants who are involuntarily incarcerated. (Note: under specific circumstances a person who has been imprisoned may be included as a participant. Strict conditions apply and BMS approval is required.)
- Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Nivolumab and Ipilimumab
Treatment will consist of Nivolumab 480mg every 4 weeks and Ipilimumab 1mg/kg every 8 weeks.
Subjects will continue on study therapy until disease progression, unacceptable toxicity, withdrawal of consent, or 24 months of therapy.
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IV infusion per institutional guidelines and the Package Insert
Other Names:
IV infusion per institutional guidelines and the Package Insert
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Progression-Free Survival at 6 Months
Time Frame: Start of treatment until 6 months later
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To determine six-month progression-free survival by iRECIST from start of study treatment until 6 months
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Start of treatment until 6 months later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival
Time Frame: start of treatment until disease progression or death, assessed up to 2 years
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to determine Progression-Free survival from start of study treatment until time of documented disease progression or death assessed up to 2 years
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start of treatment until disease progression or death, assessed up to 2 years
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Overall Survival
Time Frame: From start of treatment until death assessed up to 2 years
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Overall survival (OS) is defined as the duration of time from start of treatment to death
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From start of treatment until death assessed up to 2 years
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Objective Response Rate
Time Frame: From start of treatment until progression or death assessed up to 2 years
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The objective response rate is determined by the percentage of individuals on study attaining a complete or partial response as noted by by iRECIST and RECIST v1.1 Criteria
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From start of treatment until progression or death assessed up to 2 years
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Duration of Response
Time Frame: From the first recorded partial or complete response until progressive disease or death, whichever came first, assessed up to 2 years
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Time from the first recorded partial or complete response using RECIST v.1.1 criteria until disease progression or death
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From the first recorded partial or complete response until progressive disease or death, whichever came first, assessed up to 2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Thomas Karasic, MD, Abramson Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Neoplasms, Cystic, Mucinous, and Serous
- Cecal Diseases
- Cecal Neoplasms
- Adenocarcinoma
- Cystadenocarcinoma
- Adenocarcinoma, Mucinous
- Appendiceal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
- Ipilimumab
Other Study ID Numbers
- UPCC 28218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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John HaysAmgenUnknownMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal CancerUnited States
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National Cancer Institute (NCI)TerminatedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer | Stage IVB Colon Cancer | Stage IVB Rectal...United States
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Fox Chase Cancer CenterTerminatedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Liver Metastases | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal CancerUnited States
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Fox Chase Cancer CenterNational Cancer Institute (NCI)TerminatedMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage... and other conditionsUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnMucinous Adenocarcinoma of the Rectum | Signet Ring Adenocarcinoma of the Rectum | Mucinous Adenocarcinoma of the Colon | Signet Ring Adenocarcinoma of the Colon | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer | Stage IVB Colon Cancer | Stage IVB Rectal...United States
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