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Monoclonal Antibodies

Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (PLATforM Trial)

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization (or start of treatment for non-randomized section) to death due to any cause, assessed up to 49 months (randomized section) and 24 months (non-randomized section)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new drug, spartalizumab, can help treat people with melanoma that has spread or can't be removed by surgery.

Eligible Conditions

Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization (or start of treatment for non-randomized section) to death due to any cause, assessed up to 49 months (randomized section) and 24 months (non-randomized section)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization (or start of treatment for non-randomized section) to death due to any cause, assessed up to 49 months (randomized section) and 24 months (non-randomized section)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization (or start of treatment for non-randomized section) to death due to any cause, assessed up to 49 months (randomized section) and 24 months (non-randomized section) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response (DOR)

Overall Survival (OS)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Arm 4: LEE011 + PDR001 (randomized section)Experimental Treatment2 Interventions

Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 intravenously at a dosage of 400 mg every 4 weeks

Group II: Arm 3: ACZ885 + PDR001 (randomized section)Experimental Treatment2 Interventions

Participants randomized to receive to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks

Group III: Arm 2: INC280+PDR001 (randomized section)Experimental Treatment2 Interventions

Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 intravenously at a dosage of 400 mg every 4 weeks

Group IV: Arm 1A: LAG525 + PDR001 (non-randomized section)Experimental Treatment2 Interventions

LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks

Group V: Arm 1: LAG525 + PDR001 (randomized section)Experimental Treatment2 Interventions

Participnats randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PDR001

2016

Completed Phase 2

~2890

INC280

2014

Completed Phase 2

~1020