iSCORE: Immunotherapy Sequencing in COlon and REctal Cancer
- Conditions
- Metastatic RAS wild-type colorectal cancer which has previously responded to FOLFIRI chemotherapy and Cetuximab treatment but then progressedTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-002250-79-GB
- Lead Sponsor
- The Royal Marsden NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 25
• Male or female patients aged =18 years
• Patients with histologically confirmed advanced/metastatic RAS/RAF wild type colon or rectal adenocarcinoma who had a prior radiological response to first line treatment with FOLFIRI and Cetuximab but have subsequently progressed/ become refractory to this treatment based on physician judgment
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Estimated life expectancy of at least 3 months at the time of informed consent per Investigator assessment
• Adequate organ functioning including haematological, renal, liver and cardiac function
• Negative serum or urine pregnancy test at screening for women of childbearing potential and use of highly effective contraception for both male and female subjects throughout the study
• Patient must consent and be eligible to undergo mandatory baseline and sequential biopsies
• Presence of measurable disease as defined by RECIST v 1.1 criteria for response assessment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
• Systemic therapy within 4 weeks prior to the planned administration of the first study treatment dose
• Major surgery within 4 weeks or radiation therapy within 14 days prior to study entry. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 48 hours prior to study entry and there is at least one measurable lesion that has not been irradiated.?
• Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs
• Uncontrolled or significant cardiovascular disease including including patients with a history of myocarditis, regardless of aetiology
• Known severe hypersensitivity reactions (Grade = 3 NCI CTCAE v 5.0) to monoclonal antibodies or related compounds or any of their components
• Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
• Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive)
• Active, known or suspected autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Subjects with type I diabetes mellitis, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Patients with a history of interstitial lung disease or radiological evidence of pulmonary fibrosis
• Pregnancy or lactation
• Vaccination within 4 weeks of the first dose of study drugs and while on trial is prohibited except for administration of inactivated vaccines
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method