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Monoclonal Antibodies

Arm 2: INC280+PDR001 (randomized section) for 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

PLATforM Trial 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.

PLATforM Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Survival (OS)
+8 more

PLATforM 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
~2700
INC280
2014
Completed Phase 2
~1020
LEE011
2014
Completed Phase 3
~1960
ACZ885
2006
Completed Phase 3
~1070
LAG525
2018
Completed Phase 2
~850

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,547 Total Patients Enrolled
51 Trials studying Melanoma
30,707 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration sanctioned Spartalizumab for medicinal purposes?

"Spartalizumab's safety was judged to be a 2 on the scale of 1-3 as there is only anecdotal evidence that it may be safe, with no data yet supporting its effectiveness."

Answered by AI

Are there still vacancies available in this research endeavor?

"Currently, this research project is not enrolling participants. It was posted on September 10th 2018 and last updated on October 19th 2022. If you are still seeking trials to join, there are 754 studies for melanoma and 95 Spartalizumab clinical trials that require test subjects."

Answered by AI

What are the customary applications for Spartalizumab?

"Spartalizumab is a viable intervention for neonatal-onset multisystem inflammatory disease (NOMID), familial cold autoinflammatory syndrome (FCAS) and postmenopausal symptoms."

Answered by AI

Have prior investigations been conducted on Spartalizumab?

"Spartalizumab was initially evaluated at UCLA School of Medicine in 2011 and there have been 116 trials that are now concluded. Currently, 95 active clinical studies related to Spartalizumab exist; many of them located in Los Angeles and Massachusetts."

Answered by AI

How many venues is this clinical experiment overseen in?

"The current cohort of this clinical trial is being conducted in 10 different locations, including Los Angeles, Boston and Washington. If a patient chooses to enroll, they should select the closest site to reduce travel needs."

Answered by AI

How many participants are being monitored in this clinical trial?

"This medical trial is not currently enrolling participants. Initially posted on the 10th of September 2018, the most recent update was made on October 19th 2022. If you are seeking other studies related to melanoma there are 754 clinical trials recruiting patients and 95 for Spartalizumab specifically looking for volunteers."

Answered by AI

Is this experiment unprecedented in its scope and methodology?

"Since 2011, Spartalizumab has been extensively studied. The first experiment was conducted by Novartis Pharmaceuticals with 185 participants and Phase 1 drug approval soon followed its completion. Currently, there are 95 active studies of this medication in 627 cities across 57 nations worldwide."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
2018. "Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03484923.
~30 spots leftby Apr 2025
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