Clinical trial · Interventional
Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
A Phase II Study of Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to slow enrollment and lack of efficacy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucinous Adenocarcinoma of the Colon | Colon Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Mucinous Adenocarcinoma of the Rectum | Rectal Mucinous Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab and Ipilimumab
- description
- 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.
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab
Primary outcomes (1)
- measure
- Number of Participants With Progression-Free Survival at 6 Months
- timeFrame
- Start of treatment until 6 months later
- description
- To determine six-month progression-free survival by iRECIST from start of study treatment until 6 months
Secondary outcomes (4)
- measure
- Progression-Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) illnessReferences
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