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Platinum-containing Compound
Triple Therapy for Colorectal Cancer
Phase 2
Waitlist Available
Led By Neil Segal, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an ECOG performance status of 0 or 1.
Locally advanced unresectable or metastatic CRC.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test a new combination therapy for people with a certain type of colorectal cancer.
Who is the study for?
Adults with advanced colorectal cancer that's spread and hasn't responded to at least two standard chemotherapies can join this trial. They need a certain level of blood cells, good organ function, and no major health issues like HIV or active infections. Pregnant or breastfeeding individuals are excluded.Check my eligibility
What is being tested?
The study is testing a combination of three drugs: Temozolomide (TMZ), Cisplatin, and Nivolumab in people whose colorectal cancer has not been helped by standard treatments. It aims to see if this mix is safe and works better for those with specific genetic features in their tumors.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, lowered immunity leading to increased infection risk, potential kidney or liver issues from the drug combo. There might also be allergic reactions or skin problems due to Nivolumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My colorectal cancer cannot be removed by surgery and has spread.
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My cancer is not caused by changes in the BRAF or POLE genes.
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My kidney function is within the required range.
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I am 18 years old or older.
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My liver enzymes are within the required range.
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My diagnosis is colorectal cancer confirmed by lab tests.
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My cancer is not caused by a specific genetic mismatch repair deficiency.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response
Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Ischaemic stroke
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: temozolomide, cisplatin and nivolumabExperimental Treatment3 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide (TMZ)
2005
Completed Phase 3
~760
Cisplatin
2013
Completed Phase 3
~1940
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,602 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,496 Total Patients Enrolled
Neil Segal, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have another cancer, but it's either not growing or doesn't need treatment, except for certain skin cancers or treated cervical cancer.My recent tests show my organs are functioning well.My blood clotting tests are normal or managed if I'm on blood thinners.I am not on high-dose steroids or other drugs that weaken my immune system.My colorectal cancer cannot be removed by surgery and has spread.My cancer is not caused by changes in the BRAF or POLE genes.I haven't had cancer treatment in the last 2 weeks and have recovered from side effects.I have an autoimmune disease but it's either mild or well-controlled.I have not received treatments targeting immune checkpoints.I have not received a live vaccine in the last 30 days.My kidney function is within the required range.I am 18 years old or older.I have stable brain metastases and haven't used steroids in the last 7 days.My liver enzymes are within the required range.I have been diagnosed with HIV.I have fully recovered from any major surgery before starting treatment.I am currently being treated for an infection.My diagnosis is colorectal cancer confirmed by lab tests.My cancer is not caused by a specific genetic mismatch repair deficiency.My cancer did not respond or I couldn't tolerate at least 2 standard chemotherapies including oxaliplatin, irinotecan, and a fluoropyrimidine.My organs are working well.
Research Study Groups:
This trial has the following groups:- Group 1: temozolomide, cisplatin and nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots left for this research study?
"That is correct, based on the information available on clinicaltrials.gov this study is still recruiting patients. The trial was first announced on November 18th, 2020 with a most recent update being August 15th, 2022. They are looking for a total of 35 individuals across 7 sites."
Answered by AI
Are there similar examples of Cisplatin being tested in other medical studies?
"City of Hope Comprehensive Cancer Center was the first to study cisplatin in 1997 and, since then, 1452 other completed studies have followed. As of now, 1623 live trials are underway; a majority based in Montvale, New jersey."
Answered by AI
Could you please provide the total body count for this experiment?
"That is correct. The clinicaltrials.gov website lists this trial as currently recruiting, with a first posted date of November 18th, 2020. The study needs 35 individuals at 7 different locations."
Answered by AI
Could you please outline the possible risks associated with Cisplatin?
"Cisplatin has received a score of 2 due to there being Phase 2 trial data suggesting it is safe, but no efficacy data."
Answered by AI
Is this clinical research being conducted at a large number of hospitals in North America?
"At the moment, this clinical trial is running at 7 different hospitals. The sites are situated in Montvale and Harrison (New york) as well as other locations. If you enroll in this study, try to choose a location near you to limit travel time and expenses."
Answered by AI
What approved treatments use Cisplatin?
"Cisplatin is a medication that is used to help treat conditions such as cancer progression, disease, and unresectable melanoma. It can also be effective for treating other malignant neoplasms like squamous cell carcinoma."
Answered by AI
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