Temozolomide Cisplatin and Nivolumab in People With Colorectal Cancer

  • End date
    Jul 22, 2023
  • participants needed
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 22 March 2021


This study will test whether the combination of cisplatin, nivolumab, and temozolomide is an effective treatment for in people with advanced and/or metastatic colorectal cancer that is mismatch repair-proficient (MMR-proficient). The researchers will also look at how safe the study drug combination is in participants.

Condition Colorectal Adenocarcinoma
Treatment cisplatin, Nivolumab, Temozolomide (TMZ)
Clinical Study IdentifierNCT04457284
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on22 March 2021


Yes No Not Sure

Inclusion Criteria

Subject or legally authorized representative is willing and able to provide written informed consent/assent for the trial
Histologically- or cytologically- confirmed colorectal adenocarcinoma
Locally advanced unresectable or metastatic CRC
Undergone testing for MSI/dMMR and determined to be MSS or MMR proficient
Undergone testing for BRAF and POLE and determined to be wild type
Subjects must be refractory to, or intolerant of, at least 2 lines of standard chemotherapy, according to NCCN guidelines for patients eligible for intensive therapy, or have received prior FOLFOXIRI. Patients are considered refractory if progressed within 3 months of last dose, or within 6 months of completing adjuvant FOLFOX/CAPEOX. At a minimum, such therapies should include oxaliplatin, irinotecan and a fluoropyrimidine
At least one index lesion which is measurable based on RECIST 1.1
Be 18 years of age on day of signing informed consent
Consent for use of archival tissue and blood draws for research purposes
Have an ECOG performance status of 0 or 1
Demonstrate adequate organ function as defined in Table 6.1, all screening labs should be performed within 28 days of treatment initiation
Adequate organ function, defined as
Absolute Neutrophil Count 1,500/mcL
Platelet count 100,000/mcL
Serum creatinine 1.5 x ULN or CrCl 60 mL/min for subjects with creatinine levels >1.5 ULN
WBC 2000/L
Hemoglobin 9.0 g/dL
AST and ALT 2.5 ULN or 5 ULN for subjects with liver metastases
Bilirubin 1.5 ULN or Direct bilirubin ULN for subjects with bilirubin levels >1.5
INR/PT and PTT 1.5 X ULN unless on anticoagulant therapy and PT/PTT within therapeutic range
aCreatinine clearance should be calculated per institutional standard
Adequate method of contraception

Exclusion Criteria

Subject is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10 mg/day prednisone, or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Inhaled or topical steroids are permitted in the absence of active autoimmune disease
Prior chemotherapy, targeted small molecule therapy, or biological therapy, within 2 weeks prior to study Day 1 or who has not recovered (i.e., Grade 1 or at baseline) from adverse events due to a previously administered agent (exc. alopecia)
If subject received major surgery, they must have recovered adequately prior to starting therapy
Has a known additional malignancy that is progressing or requires active treatment
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment
Has an active, known or suspected autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy, type 1 diabetes mellitus are permitted. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
Has an active infection requiring systemic therapy
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or it is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months for females, 7 months for males after the last dose of trial treatment
Prior anti-PD-1, anti-PDL-1, anti-PDL-2, anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
Has received a live vaccine within 30 days prior to the first dose of trial treatment
Subject is a prisoners, or compulsory detained
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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