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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.

Must not have

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on high-dose steroids or other drugs that weaken my immune system.

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I haven't had cancer treatment in the last 2 weeks and have recovered from side effects.

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I have not received treatments targeting immune checkpoints.

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I have been diagnosed with HIV.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Cerebral infarction

Dyspnoea

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3120