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Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

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ClinicalTrials.gov Identifier: NCT03693846
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mucinous Neoplasm Colorectal Tumor Appendiceal Tumor Drug: Nivolumab Drug: Ipilimumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nivolumab and Ipilimumab
Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks.
Drug: Nivolumab
IV infusion per institutional guidelines and the Package Insert

Drug: Ipilimumab
IV infusion per institutional guidelines and the Package Insert




Primary Outcome Measures :
  1. Six-month progression-free survival [ Time Frame: 6 months ]
    To determine six-month progression-free survival by iRECIST



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693846


Contacts
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Contact: Peter O'Dwyer, MD 855-216-0098 penncancertrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Peter O'Dwyer    855-216-0098    penncancertrials@emergingmed.com   
Principal Investigator: Peter O'Dwyer, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Peter O'Dwyer, MD Abramson Cancer Center

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03693846     History of Changes
Other Study ID Numbers: UPCC 28218
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Appendiceal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Cecal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cecal Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents