What side effects are associated with this type of intervention?

Common treatments for Mesothelioma, particularly those involving immune modulation like SAR444245, often have side effects related to immune system activation. These can include fatigue, rash, pruritus, diarrhea, and pneumonitis. Severe adverse events may include pneumonia and other immune-related effects that might require immunosuppressive treatments. When combined with chemotherapy, additional side effects can include anemia, neutropenia, and thrombocytopenia.

What prior FDA approvals exist?

The FDA has approved several immune-modulating treatments for mesothelioma. Notably, nivolumab and ipilimumab, both immune checkpoint inhibitors, have shown efficacy in treating previously treated and relapsed mesothelioma. Nivolumab targets PD-1, while ipilimumab targets CTLA-4, both enhancing the immune system's ability to fight cancer. These treatments are similar to the immune modulation approach being studied with SAR444245.

What other types of research exist?

Promising novel alternatives to SAR444245 for mesothelioma patients include: 1) Nivolumab, an anti-PD-1 therapy, which has shown efficacy in relapsed malignant pleural mesothelioma. 2) Pembrolizumab, another anti-PD-1 therapy, which has demonstrated activity in mesothelioma in the KEYNOTE-028 trial. 3) Combination therapies such as Nivolumab with Ipilimumab (anti-CTLA-4) have also shown promising results in the INITIATE trial. 4) Tremelimumab, an anti-CTLA-4 antibody, has demonstrated therapeutic activity in malignant pleural mesothelioma. These alternatives are based on recent clinical trial data and ongoing research in the field.

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SAR444245 + Pembrolizumab for Lung Cancer and Mesothelioma

Phase 2

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be ≥18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.

All cohorts must have a measurable disease

Must not have

Comorbidity requiring corticosteroid therapy

Has received prior IL-2-based anticancer treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SAR444245 along with other cancer treatments in patients with tumors. The goal is to see if the drug can help shrink tumors and understand how it interacts with other treatments.

Who is the study for?

Adults with Stage IV NSCLC or unresectable malignant pleural mesothelioma can join. They must have measurable disease, no recent severe heart issues, good organ function, and not be pregnant/breastfeeding. Prior treatments vary by cohort: some require no prior therapy for metastatic NSCLC; others allow certain previous treatments.

What is being tested?

The trial tests SAR444245 combined with other cancer therapies to see its effect on lung cancer/mesothelioma. It aims to determine the right dose, safety profile, how the body processes it (PK), and if it causes an immune response when used with pembrolizumab.

What are the potential side effects?

While specific side effects of SAR444245 are not listed here, common ones from similar trials include fatigue, nausea, skin reactions at injection sites, potential immune-related issues affecting organs like the liver or lungs, and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old or the legal adult age in my country.

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My cancer can be measured by tests or scans.

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I have had one treatment that includes anti-PD1/PD-L1 and one chemotherapy.

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I have had 1 or 2 treatments with pemetrexed and platinum for my cancer.

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My cancer is advanced lung cancer or inoperable pleural mesothelioma.

Exclusion Criteria

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

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I need corticosteroids for another health issue.

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I have previously received IL-2-based cancer treatment.

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I do not have active brain tumors or cancer in the lining of my brain.

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I have another cancer that is getting worse or needs treatment in the last 3 years.

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My bone marrow does not function well.

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I haven't had cancer treatment or major surgery in the last 28 days.

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I have an autoimmune disease that needed treatment in the last 2 years.

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I have received an organ or tissue transplant from another person.

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I need some help with daily activities due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Assessment of SAR444245 safety profile when combined with other anticancer therapies-Serious Adverse Events

Assessment of SAR444245 safety profile when combined with other anticancer therapies-Treatment Emergent Adverse Events

Clinical benefit rate

+4 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Pneumonia aspiration

Sepsis

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort C1: :Mesotheloma 2/3rd line therapyExperimental Treatment2 Interventions

SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).

Group II: Cohort B1: Non-small cell lung cancer 2/3rd line therapyExperimental Treatment2 Interventions

SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).

Group III: Cohort A2: Non-small cell lung cancer 1rst line therapy with Tumor proportion score 1-49%Experimental Treatment2 Interventions

SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).

Group IV: Cohort A1: Non-small cell lung cancer 1rst line therapy with Tumor proportion score > 50%Experimental Treatment2 Interventions

SAR444245 + pembrolizumab, on day 1 of a 21-day treatment cycle (up 35 cycles).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

0 / 14Eligibility 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 Mesothelioma include chemotherapy, immunotherapy, and emerging immune modulation therapies. Chemotherapy, such as pemetrexed combined with cisplatin, works by killing rapidly dividing cancer cells, but it can also affect healthy cells, leading to significant side effects. Immunotherapy, including drugs like nivolumab and ipilimumab, enhances the body's immune response against cancer cells by targeting immune checkpoints like PD-1/PD-L1 and CTLA-4, which tumors use to evade immune detection. Emerging treatments like SAR444245 focus on immune modulation, aiming to boost the immune system's ability to fight cancer more effectively. These therapies are crucial for Mesothelioma patients as they offer potential for improved outcomes and may provide options for those who do not respond well to traditional treatments.

Novel and Future Treatment Options in Mesothelioma: A Systematic Review.