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Checkpoint Inhibitor

Trabectedin + Immunotherapy for Soft Tissue Sarcoma

Phase 1 & 2

Recruiting

Led By Erlinda M Gordon, MD

Research Sponsored by Sarcoma Oncology Research Center, LLC

Eligibility Criteria Checklist

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

Must have

Acceptable renal function: Creatinine ≤1.5 times ULN or ≥ 60 mL/min (using the Cockcroft Gault formula)

Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma

Must not have

Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Females who are pregnant or breast-feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating if a combination of drugs can effectively treat NSCLC.

Who is the study for?

Adults over 18 with advanced soft tissue sarcoma, either previously treated (Phase 1) or untreated (Phase 2), who understand the study and consent to participate. They must have acceptable organ function, no severe skin conditions, heart failure, bowel diseases, recent serious infections or immunosuppression. Women of childbearing age need a negative pregnancy test and all participants must agree to use effective contraception.

What is being tested?

The trial is testing combinations of Trabectedin with Ipilimumab and Nivolumab in escalating doses for first-line treatment of advanced soft tissue sarcoma. It's an open-label study where everyone knows what treatment they're getting; Phase 1 seeks safe dosages while Phase 2 tests effectiveness in untreated patients.

What are the potential side effects?

Possible side effects include fatigue, liver toxicity, immune-related reactions like inflammation in various organs or skin rashes, digestive issues such as diarrhea or colitis, hormonal imbalances due to pituitary gland problems and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine levels, is within the normal range.

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My sarcoma cannot be removed by surgery and has spread.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

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

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I have previously been treated with specific immunotherapy drugs.

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I am not pregnant or breastfeeding.

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I have received immunotherapy targeting CTLA4 or PD-1.

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I have not had ongoing or uncontrolled diarrhea in the last 4 weeks.

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I haven't had recent severe gut issues like diverticulitis or blockages in the last 6 months.

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I have an autoimmune disease like rheumatoid arthritis or lupus.

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I have a condition affecting my adrenal glands.

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I have a hormone disorder caused by my pituitary gland.

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I have tested positive for HIV/AIDS.

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I have cancer cells in the fluid around my brain and spinal cord.

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I am on immunosuppressive therapy or I am HIV positive.

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I have Crohn's disease or ulcerative colitis.

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I have heart failure or had a recent heart problem.

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My blood, kidney, or liver tests are not within the normal range.

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My skin condition covers 25% or more of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 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

Maximum tolerated dose

Secondary study objectives

Objective response rate (ORR), disease control rate (DCR)

Overall survival (OS), 6 month OS rate

Progression free survival (PFS), 6 month PFS rate

Other study objectives

Dexamethasone and immune related events

Tumor response and PD-1, PD-L1 expression in tumors

Side effects data

From 2010 Phase 3 trial • 672 Patients • NCT00113607

77%

Neutropenia

75%

Nausea

56%

Alanine Aminotransferase Increased

56%

Vomiting

49%

Leukopenia

48%

Anaemia

46%

Fatigue

42%

Aspartate Aminotransferase Increased

35%

Thrombocytopenia

33%

Constipation

33%

Anorexia

26%

Palmar-Plantar Erythrodysaesthesia Syndrome

25%

Diarrhoea

23%

Blood Alkaline Phosphatase Increased

21%

Abdominal Pain

20%

Stomatitis

19%

Pyrexia

17%

Headache

17%

Asthenia

16%

Dyspnoea

15%

Hyperbilirubinaemia

13%

Dyspepsia

13%

Alopecia

13%

Mucosal Inflammation

12%

Cough

11%

Hypokalaemia

11%

Rash

10%

Dizziness

10%

Insomnia

Oedema Peripheral

Back Pain

Anxiety

Blood Creatine Phosphokinase Increased

Hypoalbuminaemia

Pain in Extremity

Dysgeusia

Skin Hyperpigmentation

Abdominal Pain Upper

Arthralgia

Blood Creatinine Increased

Hyponatraemia

Abdominal Distension

Myalgia

Pain

Urinary Tract Infection

Febrile Neutropenia

Dry Skin

Pharyngolaryngeal Pain

Erythema

Ascites

Pulmonary Embolism

Mouth Ulceration

Pruritus

Intestinal Obstruction

Pancytopenia

Small Intestinal Obstruction

Dehydration

Subclavian Vein Thrombosis

Syncope

Colonic Obstruction

Bone Marrow Failure

Cardiac Failure Congestive

Catheter Related Complication

General Physical Health Deterioration

Non-Cardiac Chest Pain

Catheter Related Infection

Catheter Site Infection

Hypersensitivity

Bacteraemia

Neutropenic Sepsis

Neutropenic Infection

Pneumonia

Thrombosis

Renal Failure Acute

Pleural Effusion

Axillary Vein Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Trabectedin/DOXIL

DOXIL

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: Phase 1Experimental Treatment3 Interventions

Phase 1: 3-6 will be treated with escalating doses of Trabectedin every 3 weeks up to 18 doses. Dose Level 1 is 1.0 mg/m2; Dose Level 2,1.2 mg/m2; Dose Level 3,1.5 mg/m2. Beginning 2 weeks after the first dose of Trabectedin, all patients will be treated with Ipilimumab at 1 mg/kg every 12 weeks up to 5 doses, and Nivolumab at 3 mg/kg every 2 weeks up to 26 doses. Phase 2: All patients will be treated with the maximum tolerated dose of Trabectedin every 3 weeks. Beginning 2 weeks after the first dose of Trabectedin, all patients will be treated with Ipilimumab at 1 mg/kg every 12 weeks up to 5 doses, and Nivolumab at 3 mg/kg every 2 weeks up to 26 doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Trabectedin

2005

Completed Phase 3

~2580