Targeted Therapy and Avelumab in Merkel Cell Carcinoma (NCT04261855) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Targeted Therapy and Avelumab in Merkel Cell Carcinoma
Australia19 participantsStarted 2020-10-08
Plain-language 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 therapy (EBRT) in patients with metastatic Merkel cell carcinoma (mMCC).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is 18 years of age or older and who has provided written informed consent.
* Patient has histologically confirmed metastatic MCC.
* Eastern Cooperative Oncology 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 chemotherapy 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 surgery or radiotherapy.
* 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 tumour material collected
Exclusion Criteria:
* Patient is excluded if they have ever had any brain…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.