A Phase Ib/II Study of Combination Avelumab With Peptide Receptor Radionuclide Therapy or Conventional Fractionated Radiotherapy in Patients With Metastatic Merkel Cell Carcinoma

Who is this study for? Patients with metastatic merkel cell carcinoma
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Princess Alexandra Hospital
RECRUITING
Brisbane
Royal Brisbane and Women's Hospital
RECRUITING
Brisbane
Mid North Coast Cancer Institute - Coffs Harbour Health Campus
RECRUITING
Coffs Harbour
Lake Macquarie Private Hospital
RECRUITING
Gateshead
Gosford Hospital
RECRUITING
Gosford
Wyong Hospital
RECRUITING
Hamlyn Terrace
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Sir Charles Gaidner Hospital
RECRUITING
Perth
Royal North Shore Hospital
RECRUITING
Sydney
Contact Information
Primary
Melanoma and Skin Cancer Trials Coordinator
gotham@masc.org.au
+61 3 9903 9022
Time Frame
Start Date: 2020-10-08
Estimated Completion Date: 2027-07
Participants
Target number of participants: 19
Treatments
Experimental: Arm A
Avelumab plus External Beam Radiation Therapy (EBRT)
Experimental: Arm B
Avelumab plus Lutetium-177 (177Lu)-DOTATATE This treatment arm is now closed to recruitment
Sponsors
Leads: Melanoma and Skin Cancer Trials Limited

This content was sourced from clinicaltrials.gov