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Monoclonal Antibodies

Spartalizumab Safety for Cancer

Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment,
Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is assessing the safety and tolerability of spartalizumab, and will allow subjects already receiving the treatment to continue doing so.

Who is the study for?
This trial is for patients already participating in a Novartis-sponsored study, receiving spartalizumab alone or with other treatments for solid tumors. They must be benefiting from the treatment as judged by their doctor and meet all other ongoing study requirements.Check my eligibility
What is being tested?
The trial continues to evaluate the safety and tolerability of spartalizumab, an investigational drug, given either alone or alongside other treatments to those who have been taking it and are seeing positive results.See study design
What are the potential side effects?
While specific side effects aren't listed here, spartalizumab can cause reactions similar to other immune therapies which may include fatigue, skin reactions, digestive issues, and potential immune-related conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently in a Novartis study and receiving spartalizumab.
Select...
I am currently in a Novartis study and receiving spartalizumab alone or with other treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and nature of AE and SAE by subject
Number of subjects with PDR001 dose interruption and/or reduction
Secondary outcome measures
Number of subjects receiving PDR001
Subject's exposure duration

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739
83%
Aspartate aminotransferase increased
67%
Alanine aminotransferase increased
67%
Diarrhoea
50%
Pyrexia
50%
Abdominal distension
50%
Hyperphosphataemia
33%
Blood bilirubin increased
33%
Oedema peripheral
33%
Anaemia
33%
Abdominal pain
33%
Nausea
33%
Fatigue
33%
Neutrophil count decreased
33%
Pruritus
33%
Rash
17%
Epistaxis
17%
Productive cough
17%
Liver carcinoma ruptured
17%
Tinea cruris
17%
Dysgeusia
17%
Oesophageal varices haemorrhage
17%
Hyperglycaemia
17%
Blood creatinine increased
17%
Hypokalaemia
17%
Vomiting
17%
Rash pustular
17%
Sinusitis
17%
Blood creatine phosphokinase increased
17%
Weight decreased
17%
Gamma-glutamyltransferase increased
17%
Platelet count decreased
17%
Arthralgia
17%
Myalgia
17%
Insomnia
17%
Dyspnoea exertional
17%
Hot flush
17%
Headache
17%
Cough
17%
Pneumonitis
17%
Hyperthyroidism
17%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: FGF401 120 mg + PDR001 300 mg
All Patients of Combination Dose
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
Phase II: Group 2 - FGF401 120 mg QD
Phase II: Group 3 - FGF401 120 mg QD
All Patients of Single Agent FGF401
Phase I: FGF401 80 mg + PDR001 300 mg
All Patients
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 80 mg Fed
Phase I: 120 mg Fasted

Trial Design

1Treatment groups
Experimental Treatment
Group I: PDR001Experimental Treatment1 Intervention
All subjects in all combination will be entered in one arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDR001
2016
Completed Phase 2
~2700

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,123 Total Patients Enrolled

Media Library

Spartalizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04058756 — Phase 1
Solid Tumors Research Study Groups: PDR001
Solid Tumors Clinical Trial 2023: Spartalizumab Highlights & Side Effects. Trial Name: NCT04058756 — Phase 1
Spartalizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04058756 — Phase 1

Frequently Asked Questions

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

Are there supplementary investigations involving PDR001?

"The first research into PDR001 was performed at UCLA School of Medicine in 2011 and since then, 21 studies have been wrapped up. At present, there are 27 ongoing clinical trials being conducted with a focus on Portland, Oregon."

Answered by AI

Does this investigation represent a pioneering effort in the field?

"Since its first clinical trial in 2011, which was sponsored by Novartis Pharmaceuticals and included 185 participants, PDR001 has been studied extensively. After receiving Phase 1 drug approval the research went global - now there are 27 active trials involving 122 cities across 35 countries."

Answered by AI

How many participants are accepted for this medical experiment?

"To successfully complete this trial, 121 suitable candidates must be recruited. Potential participants can apply to the Providence Portland Medical Centre in Oregon or Columbia University Medical Center- New york Presbyterian in NYC."

Answered by AI

Does this medical trial have open enrollment or is it closed?

"Clinicaltrials.gov confirms that this medical trial is still searching for participants, with the initial posting on October 31st 2019 and last update occurring on August 29th 2022."

Answered by AI

Has the FDA sanctioned PDR001 for medical use?

"This clinical trial is only in its infancy, so there is limited data regarding PDR001's safety and efficacy. Consequently, it was given a score of 1 on our assessment scale."

Answered by AI

At how many sites is this trial currently being conducted?

"There are 5 sites offering this clinical trial, amongst them the Providence Portland Medical Center in Portland and Columbia University Medical Centre-New york Presbyterian in New York. Additionally, MD Anderson Cancer Centre/University of Texas MDACC is recruiting patients from Toronto as well as other locations."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments
2019. "Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04058756.
~68 spots leftby Mar 2030
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