Clinical Trial · NCT04261855

Targeted Therapy and Avelumab in Merkel Cell Carcinoma

Overview

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).

Sponsor

Canadian Cancer Trials Group

Phase

Phase 1/2

Contacts

Prof Shahneen Sandhu, MBBS, FRACP (STUDY_CHAIR)

ClinicalTrials.gov

NCT04261855

Drug / Compound

DOTATATE

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

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.
Patient has histologically confirmed metastatic MCC.

Exclusion

Patient is excluded if they have ever had any brain or leptomeningeal metastases.