Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04984733

Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer

Led by University of Southampton · Updated on 2023-11-29

18

Participants Needed

1

Research Sites

248 weeks

Total Duration

On this page

Sponsors

U

University of Southampton

Lead Sponsor

B

Bristol-Myers Squibb

Collaborating Sponsor

AI-Summary

What this Trial Is About

An open label single arm phase II trial in patients with advanced unresectable previously treated oesophagogastric adenocarcinoma which is MGMT deficient.

CONDITIONS

Official Title

Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Pathologically confirmed advanced unresectable or metastatic oesophagogastric adenocarcinoma
  • MGMT methylation present on archival tissue
  • Mismatch repair proficient (MSI-normal or MMR intact)
  • Previously treated with at least 3 months of platinum and fluoropyrimidine chemotherapy for advanced disease without progression
  • Measurable disease according to RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Able to swallow temozolomide capsules
  • Adequate organ function within 7 days before randomization, including specific blood counts, kidney function, liver enzymes, and bilirubin levels
  • All toxicities from prior cancer therapy except specified exceptions must have resolved to grade 1 or baseline
  • Women of childbearing potential must have a confirmed menstrual period and negative pregnancy test before treatment
  • WOCBP must use effective contraception during treatment and for 5 months after last dose
  • Female subjects breastfeeding must stop nursing before first dose and until 5 months after last dose
  • Men sexually active with WOCBP must use contraception during treatment and for 7 months after last dose
  • No psychological, familial, sociological, or geographical conditions that may affect compliance
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Previous treatment with temozolomide
  • Prior treatment with immune checkpoint inhibitors or drugs targeting T-cell co-stimulation
  • Active central nervous system metastases
  • Candidate for curative surgery
  • Previous malignancies unless remission achieved at least 5 years prior (except certain skin and cervical cancers)
  • Active, known, or suspected infections or autoimmune diseases except specified conditions
  • Need for systemic corticosteroids (≥10 mg prednisolone daily) or immunosuppressants within 14 days of study drug
  • Interstitial lung disease
  • Greater than grade 1 peripheral neuropathy
  • Positive for HBV, HCV indicating infection
  • Known HIV or AIDS
  • Known hypersensitivity to components of study drugs including temozolomide, nivolumab, co-trimoxazole, or dacarbazine
  • Clinically significant abnormal ECG or serious cardiac illness within past 6 months
  • Severe liver or renal impairment
  • History of drug-induced immune thrombocytopenia from trimethoprim or sulfonamides
  • Acute porphyria
  • Severe myelosuppression

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Actively Recruiting

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Research Team

E

Elizabeth Smyth

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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