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Checkpoint Inhibitor

SX-682 + Nivolumab for Colorectal Cancer

Phase 1 & 2

Recruiting

Led By Alisha Bent, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed adenocarcinoma of the colon or the rectum that is metastatic or unresectable

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Active tuberculosis (history of exposure or history of positive tuberculosis test plus presence of clinical symptoms, physical or radiographic findings)

Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy for mCRC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of SX-682 given alone or with nivolumab for colorectal cancer that has spread or can't be removed by surgery.

Who is the study for?

This trial is for adults with RAS-mutated, MSS colorectal cancer that's spread or can't be surgically removed. They must have tried at least two prior treatments and have a life expectancy of at least 12 weeks. Participants need measurable disease, adequate organ function, and no serious medical conditions or active infections like tuberculosis or hepatitis.

What is being tested?

The STOPTRAFFIC-1 trial is testing the safety and optimal dose of SX-682 alone and combined with nivolumab in advanced colorectal cancer patients. SX-682 blocks enzymes needed for tumor growth while nivolumab boosts the immune system to fight cancer cells.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions, fatigue, blood disorders, increased risk of infection, heart issues like irregular heartbeat or chest pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer in the colon or rectum cannot be removed by surgery and has spread.

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I am fully active or can carry out light work.

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I have a tissue sample from my cancer available for testing.

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My bilirubin levels are below 1.5 mg/dL, or below 3.0 mg/dL if I have Gilbert's syndrome.

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My tumor has RAS mutation and is stable in DNA repair, confirmed by specific tests.

Exclusion Criteria

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

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I have active tuberculosis.

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I have previously been treated with drugs that boost the immune system to fight my colorectal cancer.

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My heart's electrical activity shows a longer than normal pause.

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I have serious heart or blood vessel problems that affect my daily life.

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I have lung inflammation that is not caused by an infection.

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I haven't had major surgery within the last 4 weeks, except for a diagnostic biopsy.

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I have not received a live-virus vaccine in the last 30 days.

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I have lung disease or had lung inflammation treated with steroids.

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I am allergic to certain drug ingredients used in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events (AEs)

Secondary study objectives

Overall response rate (ORR)

Overall survival (OS)

Progression-free survival (PFS)

Other study objectives

Biomarker analysis

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

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: Treatment (SX-682, nivolumab)Experimental Treatment2 Interventions

MONOTHERAPY STAGE: Patients receive SX-682 orally PO BID on days 1-21 in the absence of disease progression or unacceptable toxicity. COMBINATION STAGE: Patients receive SX-682 PO BID on days 1-56 and nivolumab IV over 30 minutes on days 1 and 29. Treatment repeat every 56 days weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

0 / 14Eligibility criteria met