XCancer

Targeted Therapy and Avelumab in Merkel Cell Carcinoma

Description:

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)

Government Study Link:

NCT04261855 - Click here to see study on

ClinicalTrials.gov

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA
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.