This phase 1b trial is examining the effectiveness and safety of cibisatamab in combination with atezolizumab (Tecentriq) after treatment with obinutuzumab (Gazyva) in patients with previously treated metastatic colorectal carcinoma (mCRC).
The main outcomes to be measured will be side effects and response to treatment.
The details
A treatment option for patients with mCRC (cancer which originates in the colon or rectum which has spread to another part of the body) is with chemotherapy. Unfortunately, patients can still go on to have cancer progression. An alternative is targeted therapy or immunotherapy. Immunotherapy drugs target certain molecules of the immune system and stimulate it to attack cancer cells.
Cibisatamab,atezolizumab, and obinutuzumab are immunotherapy drugs. It is not known if cibisatamab in combination with atezolizumab after pre-treatment with obinutuzumab is effective and safe at treating mCRC.
This study is being done to investigate the effectiveness and safety of cibisatamab in combination with atezolizumab after pre-treatment with obinutuzumab in patients with previously treated mCRC. The main outcomes to be measured will be side effects and response after 5 years follow up.
Who are they looking for?
46 participants with mCRC will be recruited. Patients must have a biopsy to confirm adenocarcinoma with high carcinoembryonic antigen (CEA) levels and not be suitable for local treatment. They must have a life expectancy of more than 12 weeks with adequate end organ function. Patients must be negative for HIV, Hepatitis B and C. Women must have a pregnancy test and be on adequate contraception throughout the trial. Men must not donate sperm, should remain abstinent or use a condom during the study.
Patients cannot participate if they have brain metastases, spinal cord compression or uncontrolled tumor-related pain. They must not have uncontrolled high blood pressure, pericardial effusion, autoimmune disease, lung disease, active infection or a major surgical procedure in the last 4 weeks. Women not on contraception, who are pregnant or breastfeeding cannot take part.
How will it work
There will be one group. They will receive obinutuzumab or 2 weeks before receiving cibisatamab and atezolizumab. All three drugs will be administered by intravenous infusion. Tocilizumab (Actemra; which dampens down the immune system) will be given to manage any side effects.
Patients will be treated until disease progresses or unacceptable side effects emerge. Patients will be followed up for treatment response and side effects for up to 5 years.
