Colorectal AdenocarcinomaPhase 2NCT04457284
Temozolomide, Cisplatin, and Nivolumab in People With Colorectal Cancer
A Phase 2 study testing Temozolomide (TMZ), Cisplatin and Nivolumab in people with Colorectal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- Temozolomide (TMZ), Cisplatin and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Nov 2020to 17 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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/μL
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553
About this study
Official title: A Phase II Study of Temozolomide, Cisplatin and Nivolumab in MMR-Proficient Colorectal Cancer
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.
- Conditions
- Colorectal Adenocarcinoma
- Keywords
- Temozolomide, Cisplatin,, Nivolumab, 20-202
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temozolomide (TMZ)Drug
TMZ 150 mg/m2 Day 1 - 5 Q4W PO Cycle 1
TMZ 200 mg/m2 Day 1 - 5 Q4W PO Cycle 2 +
CisplatinDrug
Cisplatin 40 mg/m2 Q2W IV infusion Cycle 1 +
NivolumabDrug
Nivolumab 480 mg Q4W IV infusion Cycle 1 +
| Study group | Role | What they receive |
|---|---|---|
| temozolomide, cisplatin and nivolumab | Experimental | Subjects will receive oral TMZ at 150-200 mg/m2 day 1 to 5 every 4 weeks, cisplatin via IV infusion at 40 mg/m2 every two weeks (Q2W), and nivolumab via IV infusion at 480 mg every four weeks (Q4W). Receives: Drug: Temozolomide (TMZ); Drug: Cisplatin; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
will be evaluated in this study using the new international criteria proposed in RECIST 1.1 [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor and the shortest diameter of malignant lymph nodes are used with the RECIST criteria.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start18 Nov 2020
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a two-stage design, single arm, phase II study.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Neil Segal, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457284
- Sponsor's protocol ID
- 20-202
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Temozolomide, Cisplatin and Nivolumab in MMR-Proficient Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04457284
- Acronym / sponsor ID
- 20-202
- Conditions
- Colorectal Adenocarcinoma
- Keywords
- Temozolomide, Cisplatin,, Nivolumab, 20-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a two-stage design, single arm, phase II study.
| Arm | Type | Receives |
|---|---|---|
| temozolomide, cisplatin and nivolumab | Experimental | Drug: Temozolomide (TMZ), Drug: Cisplatin, Drug: NivolumabSubjects will receive oral TMZ at 150-200 mg/m2 day 1 to 5 every 4 weeks, cisplatin via IV infusion at 40 mg/m2 every two weeks (Q2W), and nivolumab via IV infusion at 480 mg every four weeks (Q4W). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temozolomide (TMZ)TMZ 150 mg/m2 Day 1 - 5 Q4W PO Cycle 1 TMZ 200 mg/m2 Day 1 - 5 Q4W PO Cycle 2 + | Drug | temozolomide, cisplatin and nivolumab |
| CisplatinCisplatin 40 mg/m2 Q2W IV infusion Cycle 1 + | Drug | temozolomide, cisplatin and nivolumab |
| NivolumabNivolumab 480 mg Q4W IV infusion Cycle 1 + | Drug | temozolomide, cisplatin and nivolumab |
Primary outcome
Response
Time frame: 1 year
will be evaluated in this study using the new international criteria proposed in RECIST 1.1 [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor and the shortest diameter of malignant lymph nodes are used with the RECIST criteria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Segal, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide (TMZ), Cisplatin and Nivolumab in people with Colorectal Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.