Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2018-000318-39-GB
EUCTR2018-000318-39-GB
Active, not recruiting
Phase 1

A phase II trial assessing nivolumab in strong class II expressing microsatellite stable colorectal cancer - ANICCA-Class II

niversity of Birmingham0 sites36 target enrollmentStarted: June 20, 2019Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsColorectal cancer (CRC)MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOpvido

Overview

Phase
Phase 1
Status
Active, not recruiting
Enrollment
36
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •Histologically confirmed locally advanced or metastatic MSS CRC with strong class II expression (greater than 50% cancer cell positivity for class II expression on immunohistochemistry).
  • •Eastern Cooperative Oncology Group (ECOG) performance status 0\-2
  • •Age \= 18 years
  • •Patients must have completed all standard of care therapy that the treating oncologist deems appropriate. Trial treatment as first line therapy is permitted if the patient has declined standard of care therapy.
  • •CT scan of chest, abdomen, pelvis within 28 days of registration demonstrating uni\-dimensionally measurable disease as per RECIST version 1\.1
  • •Demonstrate adequate haematological function:
  • •oPlatelet count \=100 x 109 /L
  • •oNeutrophils \=1\.5 x 109/L
  • •oHaemoglobin \= 90 g/L
  • •Demonstrate adequate hepatic function:

Exclusion Criteria

  • •Previous treatment with PD1/PDL1 inhibitors.
  • •Untreated symptomatic brain or leptomeningeal metastatic disease.
  • •Medical or psychiatric conditions compromising informed consent.
  • •Any medical condition which, in the opinion of the Investigator, would compromise the ability of the patient to participate in the trial or which would jeopardise compliance with the protocol.
  • •Administration of chemotherapy, radioactive or biological cancer therapy within 4 weeks prior to the first dose of trial therapy
  • •Patient has not recovered to CTCAE grade 1 or better from the Adverse Event (AE) due to cancer therapeutics administered more than 4 weeks earlier.
  • •Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • •Patient has risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra\-abdominal abscess and abdominal carcinomatosis).
  • •Patient has a known history of other malignancy, unless the patient has undergone potentially curative therapy with no evidence of that disease for 3 years.

Investigators

Similar Trials

Active, not recruiting
Phase 1
A randomised phase II trial comparing two different ways of combining nivolumab and ipilimumab in first-line treatment of patients with advanced or metastatic renal cell carcinoma.Previously untreated metastatic clear cell renal cell carcinoma.MedDRA version: 20.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-001476-33-GBniversity of Leeds189
Active, not recruiting
Phase 1
A study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with Hodgkin Lymphoma
EUCTR2017-001939-38-FRYSARC64
Active, not recruiting
Phase 1
A study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with Hodgkin Lymphomapatients aged 61 years and older, with classical Hodgkin lymphoma and coexisting medical conditionsMedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-001939-38-BEYSARC64
Active, not recruiting
Phase 2
A phase II trial to find the durable clinical benefit of nivolumab in class II expressing microsatellite colorectal cancerColorectal cancerCancer
ISRCTN40245896niversity of Birmingham36
Active, not recruiting
Phase 1
A randomized, run-in, phase II study of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab in melanoma and NSCLC patients resistant to anti-PD-1/PD-L1MM and NSCLC patients resistant to anti-PD-1/PD-L1 therapyMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2019-002986-36-ITFONDAZIONE NIBIT NETWORK ITALIANO PER LA BIOTERAPIA DEI TUMORI184