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spartalizumab for Breast Cancer

Phase 1
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 at month 18
Awards & highlights

Study Summary

This trial is a Phase Ib, open label, dose escalation study of spartalizumab + LAG525 in combination with NIR178, capmatinib, MCS110, or canakinumab, followed by a dose expansion in adult patients with advanced or metastatic TNBC.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose intensities
Frequency of dose interuptions
Frequency of dose reductions
+3 more
Secondary outcome measures
Best overall response (BOR)
Changes from baseline of PD markers in tumor tissue (TILs, CD8, PD-L1, LAG-3)
PK parameter (AUC) of LAG525
+24 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: 4: spartalizumab +LAG525 +canakinumabExperimental Treatment3 Interventions
phase Ib (escalation and expansion)
Group II: 3: spartalizumab + LAG525 + MCS110Experimental Treatment3 Interventions
phase Ib (escalation and expansion)
Group III: 2: spartalizumab +LAG525 +capmatinibExperimental Treatment3 Interventions
phase Ib (escalation and expansion)
Group IV: 1: spartalizumab + LAG525 + NIR178Experimental Treatment3 Interventions
phase Ib (escalation and expansion)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
canakinumab
2014
Completed Phase 3
~280
LAG525
2018
Completed Phase 2
~850
MCS110
2012
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,641 Total Patients Enrolled
88 Trials studying Breast Cancer
37,812 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Has the FDA certified spartalizumab for public use?

"Spartalizumab's safety ranking on a scale of 1 to 3 is 1, due to it being in Phase I trials and the lack of data supporting its efficacy."

Answered by AI

Would this research be considered pioneering in its field?

"Research into spartalizumab began in 2011 with an initial trial sponsored by Novartis Pharmaceuticals. This first study had 185 participants, and it led to the drug's Phase 1 approval. There are currently 52 active studies for spartalizumab spread across 352 cities and 54 countries."

Answered by AI

What is the maximum capacity of participants for this medical research?

"Unfortunately, this trial is not accepting any new patients at present. Initially posted on January 31st 2019, the study has been recently modified as of November 18th 2022. At the moment there are 2351 trials for breast cancer and 52 studies using spartalizumab that are actively enrolling participants if you wish to explore other options."

Answered by AI

What has spartalizumab been demonstrated to be beneficial for?

"Spartalizumab is most commonly prescribed to treat neonatal-onset multisystem inflammatory disease (nomid). Additionally, it can be utilized for familial cold autoinflammatory syndrome (fcas), muckle-wells syndrome (mws), and active systemic juvenile idiopathic arthritis."

Answered by AI

Is recruitment for this trial still open to participants?

"As found on clinicaltrials.gov, the trial is not presently looking for participants. First posted in January of 2019 and last updated November 18th 2022, there are no more recruitment efforts taking place at this time; however, 2403 other studies are still enrolling patients."

Answered by AI

Can you summarize the results of prior experiments pertaining to spartalizumab?

"Currently, there are 52 studies being conducted on spartalizumab. Out of those trials, 7 have reached Phase 3 and further 1364 medical centres across the country are participating in this research. Notably, many of these sites are located within New york City itself."

Answered by AI
~10 spots leftby Apr 2025