Study to evaluate the efficacy and safety of novel spartalizumab combinations in patients with previously treated unresectable or metastatic melanoma

Phase 1

• Conditions: nresectable or metastatic melanoma; MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000610-38-FR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-16
• Last Update Posted: 17 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Histologically confirmed unresectable or metastatic stage IIIB/C/D or IV melanoma using AJCC edition 8
• Previously treated for unresectable or metastatic melanoma. Subjects must have at least received the following treatments:
-V600BRAF wild-type patients: must have received anti-PD-1/PD-L1 single-agent, or in combination with anti-CTLA-4 therapy
-V600BRAF mutant patients: must have received prior anti-PD-1/PD-L1 single-agent, or in combination with anti-CTLA-4 therapy. In addition, subjects must have received prior V600BRAF inhibitor therapy, either single-agent or in combination with a MEK inhibitor
• ECOG performance status 0-2
• At least one measurable lesion per RECIST v1.1
• At least one lesion, suitable for sequential mandatory tumor biopsies (screening and on-treatment) in accordance with the biopsy guidelines specified in protocol. The same lesion must be biopsied sequentially.
• Screening tumor biopsy must fulfill the tissue quality criteria outlined in the protocol, as assessed by a local pathologist

Other inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• Subjects with uveal or mucosal melanoma
• Presence of clinically active or unstable brain metastasis. Note: Subjects with unstable brain lesions who have been definitively treated with stereotactic radiation therapy, surgery or gamma knife therapy are eligible.
- Subjects with brain lesions who are untreated (i.e. newly discovered brain lesions during screening) or received whole brain radiation must have documented stable disease as assessed by two consecutive assessments = 4 weeks apart and have not required steroids for at least = 4 weeks prior to enrollment.
• Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
• Active infection requiring systemic antibiotic therapy.
• Systemic chronic steroid therapy (> 10mg/day prednisone or equivalent) or any other immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Local steroids such as topical, inhaled, nasal and
ophthalmic steroids are allowed.
• Active, known or suspected autoimmune disease or a documented history of autoimmune disease. Note:
Subjects with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmunerelated
hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted.
• Prior allogenic bone marrow or solid organ transplant
• History of known hypersensitivity to any of the investigational drugs used in this study

Other exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified