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

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

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

Must not have

Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the Roll over Study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to ensure that spartalizumab remains safe and tolerable for patients who are already using it. The medication helps the immune system fight cancer, and the study ensures patients can keep accessing it safely.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was taken off spartalizumab for reasons other than joining another study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency and nature of AE and SAE by subject

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739

73%

Diarrhoea

48%

Aspartate aminotransferase increased

43%

Alanine aminotransferase increased

27%

Decreased appetite

23%

Nausea

20%

Blood bilirubin increased

20%

Pyrexia

19%

Fatigue

19%

Vomiting

19%

Oedema peripheral

19%

Abdominal pain

17%

Pruritus

15%

Asthenia

14%

Constipation

13%

Anaemia

12%

Blood alkaline phosphatase increased

12%

Cough

12%

Abdominal pain upper

11%

Ascites

11%

Gamma-glutamyltransferase increased

10%

Dyspnoea

10%

Insomnia

Abdominal distension

Back pain

Weight decreased

Lipase increased

Hyperphosphataemia

Hypoalbuminaemia

Headache

Musculoskeletal pain

Hyponatraemia

Dry skin

Rash

Hypertension

Dysgeusia

Nasopharyngitis

Procedural pain

Productive cough

Platelet count decreased

Chills

Blood creatine phosphokinase increased

Anxiety

Hyperlipasaemia

Myalgia

Dysphagia

Dry mouth

Rhinitis

Arthralgia

Blood creatinine increased

Hyperglycaemia

Gastrooesophageal reflux disease

Hypokalaemia

Haemoptysis

Hepatic pain

Abdominal discomfort

Upper gastrointestinal haemorrhage

Dizziness

Epistaxis

Stomatitis

Dyspepsia

Melaena

Hyperkalaemia

Bronchitis

Jaundice

Pleural effusion

Oesophageal varices haemorrhage

Haematemesis

Peripheral swelling

Hyperbilirubinaemia

Hypertriglyceridaemia

Night sweats

Neutrophil count decreased

Pain in extremity

Hepatocellular injury

Malaise

Oedema

Pain

Leukopenia

Duodenal ulcer

Pneumonia

Urinary tract infection

Amylase increased

C-reactive protein increased

Transaminases increased

Hypercalcaemia

Hypophosphataemia

Flank pain

Muscle spasms

Musculoskeletal chest pain

Oropharyngeal pain

Dysphonia

Depression

Palpitations

Gastroenteritis

Paraparesis

Groin pain

Gastrointestinal haemorrhage

Haemorrhoids

Folliculitis

Hypoglycaemia

Gastritis

Lymphopenia

Oesophageal stenosis

Dyspnoea exertional

Venous thrombosis

Hepatic cirrhosis

Vertigo

Pneumonitis

Hypovolaemic shock

Peripheral sensory neuropathy

Cholangitis

Spinal cord compression

Varices oesophageal

Spinal pain

Biloma

Herpes zoster

Calculus urinary

Atelectasis

Thrombocytopenia

Animal bite

Hepatic function abnormal

Bone contusion

Malnutrition

Sleep disorder

Gastric varices

Gait disturbance

Abdominal tenderness

Hypomagnesaemia

Confusional state

Blood albumin decreased

Pulmonary embolism

Gastrointestinal sounds abnormal

Duodenal obstruction

Sinusitis

Bilirubin conjugated increased

Female genital tract fistula

Bronchostenosis

Haemorrhoidal haemorrhage

Prothrombin time prolonged

Cancer pain

Rash pustular

Oesophageal ulcer

Hyperuricaemia

Tumour associated fever

Tumour thrombosis

Hepatomegaly

Hepatorenal syndrome

General physical health deterioration

Hernia

Acute coronary syndrome

Coronary artery disease

Cholestasis

Hepatic haematoma

Pyelonephritis acute

Varicella

Carotid artery stenosis

Cerebrovascular accident

Dysarthria

Haemorrhage intracranial

Paraesthesia

Paraplegia

Urinary retention

Aneurysm

Bleeding varicose vein

Hyperglobulinaemia

Hyperthyroidism

Angular cheilitis

Toothache

Chest discomfort

Jaundice cholestatic

Candida infection

Herpes virus infection

Tinea cruris

Activated partial thromboplastin time prolonged

Blood cholesterol increased

Blood phosphorus decreased

Haemoglobin decreased

Osteoporosis

Visual field defect

Scrotal oedema

Varicocele

Rash macular

Rash maculo-papular

Haematoma

Hot flush

Multiple organ dysfunction syndrome

Lung infection

Liver carcinoma ruptured

Acute kidney injury

Bronchial obstruction

Vena cava thrombosis

Inferior vena caval occlusion

100%

80%

60%

40%

20%

Study treatment Arm

All Patients

Phase I: 80 mg Fed

Phase I: 50 mg Fasted

Phase I: 80 mg Fasted

Phase I: 120 mg Fasted

Phase I: 120 mg Fed

Phase I: 150 mg Fasted

Phase II: Group 1 - FGF401 120 mg QD

Phase I: FGF401 80 mg + PDR001 300 mg

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 120 mg + PDR001 300 mg

All Patients of Combination Dose

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2890

0 / 3Eligibility 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.