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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

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 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
9%
Oedema Peripheral
9%
Back Pain
7%
Anxiety
7%
Blood Creatine Phosphokinase Increased
7%
Hypoalbuminaemia
6%
Pain in Extremity
6%
Dysgeusia
6%
Skin Hyperpigmentation
6%
Abdominal Pain Upper
6%
Arthralgia
6%
Blood Creatinine Increased
6%
Hyponatraemia
5%
Abdominal Distension
5%
Myalgia
5%
Pain
5%
Urinary Tract Infection
5%
Febrile Neutropenia
5%
Dry Skin
5%
Pharyngolaryngeal Pain
5%
Erythema
4%
Ascites
4%
Pulmonary Embolism
3%
Mouth Ulceration
3%
Pruritus
2%
Intestinal Obstruction
2%
Pancytopenia
2%
Small Intestinal Obstruction
2%
Dehydration
1%
Subclavian Vein Thrombosis
1%
Syncope
1%
Colonic Obstruction
1%
Bone Marrow Failure
1%
Cardiac Failure Congestive
1%
Catheter Related Complication
1%
General Physical Health Deterioration
1%
Non-Cardiac Chest Pain
1%
Catheter Related Infection
1%
Catheter Site Infection
1%
Hypersensitivity
1%
Bacteraemia
1%
Neutropenic Sepsis
1%
Neutropenic Infection
1%
Pneumonia
1%
Thrombosis
1%
Renal Failure Acute
1%
Pleural Effusion
1%
Axillary Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trabectedin/DOXIL
DOXIL

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
2014
Completed Phase 3
~5220
Trabectedin
2005
Completed Phase 3
~2580
Ipilimumab
2014
Completed Phase 3
~3140

Find a Location

Who is running the clinical trial?

Sarcoma Oncology Research Center, LLCLead Sponsor
8 Previous Clinical Trials
521 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,600 Total Patients Enrolled
Erlinda M Gordon, MDPrincipal InvestigatorSarcoma Oncology Research Center
3 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03138161 — Phase 1 & 2
Soft Tissue Sarcoma Research Study Groups: Phase 1
Soft Tissue Sarcoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03138161 — Phase 1 & 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03138161 — Phase 1 & 2
~1 spots leftby Dec 2024
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