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NCT03484923 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Melanoma, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
196
Enrollment target
20
Study locations

NCT03484923: Completed Phase 2 study of Melanoma, sponsored by Novartis Pharmaceuticals.

NCT03484923 is a Phase 2 study of Melanoma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 196 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03484923, a Phase 2 study of Melanoma, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
196 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma

Primary Outcome

ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI). CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At leas

Conditions Studied

Interventions

  • DRUG LEE011
  • DRUG PDR001
  • DRUG INC280
  • DRUG LAG525
  • DRUG ACZ885

Study Locations (20)

Other

  • Novartis Investigative Site - Marseille
  • Novartis Investigative Site - Paris
  • Novartis Investigative Site - Villejuif
  • Novartis Investigative Site - Dresden
  • Novartis Investigative Site - Essen
  • Novartis Investigative Site - Hamburg
  • Novartis Investigative Site - Kiel
  • Novartis Investigative Site - München

California

  • The Angeles Clinic and Research Institute - Los Angeles
  • University of California Los Angeles - Los Angeles
  • UCSF Medical Center . - San Francisco

New South Wales

  • Novartis Investigative Site - North Sydney
  • Novartis Investigative Site - Westmead

Massachusetts

  • Massachusetts General Hospital Massachusetts Gen. Hospital CC - Boston

New York

  • NYU Laura and Isaac Perlmutter Cancer Center Perlmutter Cancer Center - New York

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Ontario

  • Novartis Investigative Site - Toronto

Quebec

  • Novartis Investigative Site - Montreal

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2018-09-10
Est. Completion 2022-12-30
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT03484923 record still lists

NCT03484923 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (72% lower).

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 5 interventions - of which LEE011 is the first listed.

NCT03484923 names 20 study sites across 10 states, led by Other, California, New South Wales.

Frequently Asked Questions

What is clinical trial NCT03484923 about?

NCT03484923 is a clinical study titled "Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma". The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma

What is the current status of trial NCT03484923?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2018-09-10. Estimated completion is 2022-12-30.

What conditions does trial NCT03484923 study?

This clinical trial studies the following conditions: Melanoma.

What interventions are being tested in trial NCT03484923?

The interventions under investigation include: LEE011 (DRUG), PDR001 (DRUG), INC280 (DRUG), LAG525 (DRUG), ACZ885 (DRUG).

Who is sponsoring clinical trial NCT03484923?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03484923 being conducted?

This trial has 20 study locations across California, Massachusetts, New York, Pennsylvania, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Melanoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03484923's enrollment target sits among peer trials

196 69th of 266 higher than 198 of 266 other Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03484923, the US trial registry maintained by the National Library of Medicine. NCT03484923 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.