"NEOadjuvant Plus Adjuvant Therapy With Combination or Sequence of Vemurafenib, cobImetinib, and atezolizuMab in Patients With High-risk, Surgically Resectable BRAF Mutated and Wild-type Melanoma" (NEO-TIM)

NCT04722575 Phase 2 ACTIVE_NOT_RECRUITING

Neoadjuvant plus adjuvant treatment with target therapy and immunotherapy given in combination or sequence may have an anti-tumour activity and may reduce the risk of relapse in patients with high-risk resectable melanoma (stage III B / C / D and oligometastatic stage IV).

Details

Lead sponsor	Fondazione Melanoma Onlus
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	95
Start date	2020-10-12
Completion	2027-06

Conditions

• Melanoma

Interventions

• Cobimetinib 20 MG Oral Tablet
• Vemurafenib 240 Mg Oral Capsule
• Atezolizumab 1200 MG in 20 ML Injection

Primary outcomes

• Pathologic Complete Response (pCR) rate (Centrally/Independently determined) — At surgery (from week 8 to week 9)
  Defined as the lack of all signs of cancer in tissue samples removed during surgery

Countries

Italy