What side effects are associated with this type of intervention?

Common side effects of PD-1 inhibitors like Spartalizumab in the treatment of solid tumors include fatigue, rash, and diarrhea. Severe (≥grade 3) adverse effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. These immune-related adverse events occur due to the mechanism of action of PD-1 inhibitors, which enhance the immune system's activity against cancer cells but can also lead to inflammation in normal tissues.

What prior FDA approvals exist?

Several PD-1 inhibitors have received FDA approval for the treatment of solid tumors. Pembrolizumab, a PD-1 inhibitor, has been approved for various cancers, including non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma, among others. Nivolumab, another PD-1 inhibitor, is approved for NSCLC, melanoma, renal cell carcinoma, and more. These drugs work by blocking the PD-1 pathway, thereby enhancing the immune system's ability to fight cancer. Both pembrolizumab and nivolumab have shown significant efficacy in improving progression-free survival (PFS) and overall survival (OS) in multiple clinical trials, making them pivotal in the treatment of various solid tumors.

What other types of research exist?

Promising alternatives to Spartalizumab for solid tumor patients include: 1) Pembrolizumab (Keytruda) in combination with other agents such as lenvatinib or axitinib, which has shown efficacy in various cancers including renal cell carcinoma and melanoma. 2) Nivolumab (Opdivo) combined with ipilimumab, which has demonstrated significant benefits in melanoma and renal cell carcinoma. 3) Atezolizumab (Tecentriq) in combination with bevacizumab, particularly for renal cell carcinoma. These combinations have shown improved outcomes in clinical trials and are expected to be significant treatment options in 2024.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

58%

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

Oesophageal varices haemorrhage

Flank pain

Dysgeusia

Myalgia

Tinea cruris

Hyperglycaemia

Liver carcinoma ruptured

Oedema

Blood creatinine increased

Hypokalaemia

Palpitations

Abdominal discomfort

Headache

Constipation

Vomiting

Folliculitis

Rash pustular

Sinusitis

Bilirubin conjugated increased

Blood albumin decreased

Blood creatine phosphokinase increased

Blood phosphorus decreased

Weight decreased

Platelet count decreased

Hyponatraemia

Insomnia

Dyspnoea exertional

Peripheral sensory neuropathy

Cough

Dysphonia

Epistaxis

Pneumonitis

Productive cough

Dry skin

Hyperthyroidism

Blood alkaline phosphatase increased

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

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.