Mucinous Adenocarcinoma of the Rectum Clinical Trial
Official title:
A Phase II Study of Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
Verified date | September 2022 |
Source | Abramson Cancer Center of the University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-arm phase II study of twenty-one subjects with mucinous adenocarcinoma of the colon, rectum, or appendix with prior systemic therapy with a fluoropyrimidine, oxaliplatin, and irinotecan. Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks until disease progression, unacceptable toxicity, or 2 years of therapy.
Status | Terminated |
Enrollment | 11 |
Est. completion date | March 6, 2021 |
Est. primary completion date | March 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Progression-Free Survival at 6 Months | To determine six-month progression-free survival by iRECIST from start of study treatment until 6 months | Start of treatment until 6 months later | |
Secondary | Progression-Free Survival | to determine Progression-Free survival from start of study treatment until time of documented disease progression or death assessed up to 2 years | start of treatment until disease progression or death, assessed up to 2 years | |
Secondary | Overall Survival | Overall survival (OS) is defined as the duration of time from start of treatment to death | From start of treatment until death assessed up to 2 years | |
Secondary | Objective Response Rate | 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 | From start of treatment until progression or death assessed up to 2 years | |
Secondary | Duration of Response | Time from the first recorded partial or complete response using RECIST v.1.1 criteria until disease progression or death | 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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