Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Tremelimumab; Durvalumab; Best Supportive Care
Intervention MeSH terms: Durvalumab; Tremelimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The standard or usual treatment for this disease is treatment with drugs and other treatments
      that may help to make a patient better or may improve their quality of life. This treatment
      is known as "best supportive care" (BSC). Although patients with best supportive care can
      feel better for some months, the cancer usually continues to grow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have histologically or pathologically confirmed advanced (metastatic or locally
             advanced) colorectal cancer that is unresectable.

          -  Received a prior thymidylate synthase inhibitor (e.g. 5-fluorouracil (5-FU),
             capecitabine, raltitrexed, UFT) for metastatic disease or as adjuvant therapy. A
             thymidylate synthase inhibitor may have been given in combination with oxaliplatin or
             irinotecan.

          -  Received and failed an irinotecan -containing regimen (i.e. single-agent or in
             combination) for treatment of metastatic disease, OR relapsed within 6 months of
             completion of an irinotecan-containing adjuvant therapy, OR have documented
             unsuitability for an irinotecan-containing regimen.

          -  Received and failed an oxaliplatin-containing regimen (i.e. single-agent or in
             combination) for treatment of metastatic disease, OR relapsed within 6 months of
             completion of an oxaliplatin-containing adjuvant therapy OR have documented
             unsuitability for an oxaliplatin-containing regimen.

          -  For patients with colorectal cancer that is RAS-wild type:

        Received and failed a cetuximab or panitumumab-containing regimen (i.e. single-agent or in
        combination) for treatment of metastatic disease OR have documented unsuitability for a
        cetuximab or panitumumab-containing regimen

          -  Patient prior treatment with VEGF targeting therapy, such as bevacizumab, aflibercept,
             ramucirumab, or regorafenib, is permitted but not mandatory. Reasons not used are to
             be documented.

          -  Patient prior treatment with TAS-102 (an agent composed of a combination of
             trifluorothymidine (FTD) and tipiracil hydrochloride (TPI)), is permitted but not
             mandatory.

          -  The only remaining standard available therapy as recommended by the Investigator, in
             consultation with the patient, is best supportive care.

          -  Must have presence of measurable or evaluable disease as defined by Response
             Evaluation Criteria in Solid Tumours (RECIST 1.1).

          -  Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as
             necessary to document all sites of disease done within 28 days prior to randomization.

          -  Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Life expectancy of ≥ 12 weeks at the time of study entry.

          -  Must be ≥ 18 years of age.

          -  Women/men of childbearing potential must have agreed to use a highly effective
             contraceptive method.

          -  Patient must consent to provision of, and investigator(s) must confirm adequacy of
             tissue, and confirm access to and agree to submit within 4 weeks of randomization to
             the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour
             tissue in order that the specific correlative marker assays may be conducted.

          -  Patient must consent to provision of samples of blood in order that the specific
             correlative marker assays

          -  Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life
             questionnaires in either English or French.

        Patients must be accessible for treatment and follow-up. Investigators must assure
        themselves the patients randomized on this trial will be available for complete
        documentation of the treatment, adverse events, and follow-up.

          -  In accordance with CCTG policy, protocol treatment is to begin within 2 working days
             of patient randomization.

          -  The patient is not receiving therapy in a concurrent clinical study and the patient
             agrees not to participate in other clinical studies during their participation in this
             trial while on study treatment.