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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
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 • NCT0232573958%
Diarrhoea
50%
Aspartate aminotransferase increased
42%
Hyperphosphataemia
33%
Pyrexia
33%
Anaemia
33%
Alanine aminotransferase increased
25%
Blood bilirubin increased
25%
Abdominal distension
25%
Fatigue
17%
Neutrophil count decreased
17%
Oedema peripheral
17%
Abdominal pain
17%
Nausea
17%
Nasopharyngitis
17%
Gamma-glutamyltransferase increased
17%
Arthralgia
17%
Back pain
17%
Rash
17%
Pruritus
17%
Hot flush
8%
Flank pain
8%
Dysgeusia
8%
Oesophageal varices haemorrhage
8%
Myalgia
8%
Tinea cruris
8%
Hyperglycaemia
8%
Liver carcinoma ruptured
8%
Oedema
8%
Blood creatinine increased
8%
Hypokalaemia
8%
Palpitations
8%
Abdominal discomfort
8%
Headache
8%
Constipation
8%
Vomiting
8%
Folliculitis
8%
Rash pustular
8%
Sinusitis
8%
Bilirubin conjugated increased
8%
Blood albumin decreased
8%
Blood creatine phosphokinase increased
8%
Blood phosphorus decreased
8%
Weight decreased
8%
Platelet count decreased
8%
Hyponatraemia
8%
Insomnia
8%
Dyspnoea exertional
8%
Peripheral sensory neuropathy
8%
Cough
8%
Dysphonia
8%
Epistaxis
8%
Pneumonitis
8%
Productive cough
8%
Dry skin
8%
Hyperthyroidism
8%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Patients of Combination Dose
Phase I: FGF401 120 mg + PDR001 300 mg
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects.
Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, sparing most normal cells and reducing side effects. Immunotherapy, including PD-1 inhibitors like Spartalizumab, works by blocking the PD-1 pathway, which tumors use to evade the immune system.
By inhibiting this pathway, immunotherapy reactivates the immune system to recognize and destroy cancer cells. This is particularly important for solid tumor patients as it offers a treatment option that can be more specific and potentially less toxic than traditional chemotherapy, improving both survival and quality of life.
Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.
Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,868 Previous Clinical Trials
4,199,768 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was taken off spartalizumab for reasons other than joining another study.I am currently in a Novartis study and receiving spartalizumab.I am benefiting from the current treatment, as confirmed by my doctor.I am currently in a Novartis study and receiving spartalizumab alone or with other treatments.There may be other requirements to participate in the study as outlined in the study guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: PDR001
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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