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Monoclonal Antibodies

Sacituzumab Govitecan for Mesothelioma

Phase 2

Recruiting

Led By Michael Offin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Adequate organ function: Absolute neutrophil count ≥ 1.5K/mcL, Platelet count ≥ 100K/mcL, Adequate renal function defined as creatinine clearance ≥ 30ml/min, Hemoglobin > 9g/dL, Total bilirubin ≤1.5 x upper limit of normal (ULN) if no liver metastases or <3 × ULN in the presence of documented Gilbert's Syndrome, AST, ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 × ULN)

Pathologically confirmed diffuse pleural mesothelioma

Must not have

Prior cytotoxic/immunologic systemic therapy within 3 weeks prior to study Day 1 or has not recovered from clinically significant adverse events due to a previously administered agent

History of myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or coronary/peripheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial involves giving participants a drug called sacituzumab govitecan until their condition worsens, they experience severe side effects, or it is determined by either the participant or the doctor that

Who is the study for?

This trial is for adults over 18 with confirmed diffuse pleural mesothelioma who've had at least one prior systemic therapy. They must have measurable disease, good organ function, and an ECOG score of 0 or Karnofsky Performance Status ≥70%. Participants need to consent to biopsies and use effective contraception if applicable. Exclusions include recent other treatments, certain heart conditions, active infections like hepatitis B/C or HIV, other progressing cancers (with some exceptions), and pregnancy.

What is being tested?

The study tests Sacituzumab Govitecan in patients with mesothelioma until they experience disease progression, intolerable side effects, or decide with their doctor that it's best to stop. The drug is given repeatedly over time as long as it's safe and potentially beneficial.

What are the potential side effects?

Sacituzumab Govitecan can cause severe side effects which may lead participants to stop treatment; these could include allergic reactions due to hypersensitivity to the drug components (similarly seen in irinotecan), blood disorders affecting neutrophils and platelets, liver issues reflected by bilirubin levels, kidney problems measured by creatinine clearance rate.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis is diffuse pleural mesothelioma.

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I am 18 years old or older.

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I am fully active or able to care for myself.

Exclusion Criteria

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

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I haven't had chemotherapy or immunotherapy in the last 3 weeks or still have side effects.

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I haven't had a heart attack, stroke, or major heart surgery in the last 6 months.

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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.

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I am not currently in another study nor have I used any investigational drugs or devices in the last 3 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Overall Response Rate

Side effects data

From 2020 Phase 3 trial • 529 Patients • NCT02574455

40%

Fatigue

30%

Nausea

27%

Anaemia

25%

Neutropenia

23%

Constipation

21%

Decreased appetite

20%

Neutrophil count decreased

18%

Cough

18%

Dyspnoea

17%

Diarrhoea

16%

Alopecia

16%

Vomiting

13%

Hypokalaemia

13%

Headache

13%

Back pain

13%

Asthenia

12%

Pyrexia

12%

Aspartate aminotransferase increased

11%

Oedema peripheral

11%

Neuropathy peripheral

10%

Alanine aminotransferase increased

10%

White blood cell count decreased

Urinary tract infection

Myalgia

Pain in extremity

Platelet count decreased

Arthralgia

Dizziness

Abdominal pain

Weight decreased

Mucosal inflammation

Lymphocyte count decreased

Bone pain

Hypomagnesaemia

Hypertension

Thrombocytopenia

Stomatitis

Insomnia

Pain

Rash

Blood alkaline phosphatase increased

Hyperglycaemia

Oropharyngeal pain

Hypophosphataemia

Anxiety

Abdominal pain upper

Breast pain

Upper respiratory tract infection

Musculoskeletal chest pain

Dysgeusia

Lymphoedema

Pruritus

Pleural effusion

Gastrooesophageal reflux disease

Chills

Nasopharyngitis

Hypocalcaemia

Febrile neutropenia

Sepsis

Pneumonia

Nasal congestion

Dyspnoea exertional

Dry skin

Rash maculo-papular

Pericardial effusion

Pulmonary embolism

Respiratory failure

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment of Physician's Choice (TPC)

Sacituzumab Govitecan

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: Participants with MesotheliomaExperimental Treatment1 Intervention

Participants will have pathologically confirmed diffuse pleural mesothelioma. Patients will undergo cross-sectional imaging after the first 2 cycles and subsequently after every 3 cycles until disease progression. Biopsies will take place at screening, prior to cycle 3, and an optional biopsy at the end of treatment if consent was obtained and deemed to be safe and feasible.

0 / 8Eligibility criteria met