Brief Summary
10.17 GoTHAM is intended as a signal-seeking, biomarker, phase Ib/II study that will evaluate the safety and anti-tumour activities of the novel combination of avelumab with 177-Lu-DOTATATE (a type of peptide receptor radionuclide therapy; PRRT) or external beam radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells (EBRT) in patients with metastatic Merkel cell carcinomacancer arising from tissues that line organs (mMCC).
Intervention / Treatment
- Drug: Avelumab
- Radiation: External Beam Radiation Therapy (EBRT)
- Radiation: Lutetium-177 (177Lu)-DOTATATE
Inclusion Criteria
- Patient is 18 years of age or older and who has provided written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
- Patient has histologically confirmed metastatic MCC.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of ≤2 .
- Willing and able to comply with all study protocol requirements for the duration of the study.
- Patient must have measurable disease by CT or MRI per RECIST version 1.1 criteria.
- Patient is treatment naïve (no prior systemic therapy for unresectable or metastatic MCC). Note that prior chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells is permitted in the adjuvant setting for loco-regional disease. Prior radiation is permitted for treatment of the primary or loco-regional disease.
- At least 2 weeks since the completion of prior therapy, including surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence or radiotherapy.
- Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening laboratory values, obtained within 14 days prior to registration/randomisation must meet the criteria specified in the protocol.
- Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception
- WOCBP must have a negative serum or urine pregnancy test within within 7 days prior to the start of avelumab treatment and should be performed every 4 weeks in line with other safety bloods or clinical reviews.
- Male patients who are sexually active with a WOCBP must use any contraceptive method with a failure rate of less than 1% per year.
- Patient must be agreeable to have archival tumoura tissue mass that forms from groups of unhealthy cells material collected