Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
My sarcoma cannot be removed by surgery and has spread.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose
Secondary outcome measures
Objective response rate (ORR), disease control rate (DCR)
Overall survival (OS), 6 month OS rate
Progression free survival (PFS), 6 month PFS rate
Other outcome measures
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 • NCT0011360777%
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
~4750
Trabectedin
2005
Completed Phase 3
~3090
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Sarcoma Oncology Research Center, LLCLead Sponsor
7 Previous Clinical Trials
521 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,469 Total Patients Enrolled
Erlinda M Gordon, MDPrincipal InvestigatorSarcoma Oncology Research Center
3 Previous Clinical Trials
94 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with specific immunotherapy drugs.My kidney function, measured by creatinine levels, is within the normal range.I am not pregnant or breastfeeding.I have received immunotherapy targeting CTLA4 or PD-1.I am not pregnant and agree to use effective birth control during and after the study.I have not had ongoing or uncontrolled diarrhea in the last 4 weeks.I haven't had recent severe gut issues like diverticulitis or blockages in the last 6 months.I have an autoimmune disease like rheumatoid arthritis or lupus.My sarcoma cannot be removed by surgery and has spread.I have a condition affecting my adrenal glands.I am 18 years old or older.My brain metastases are treated, and I've been stable without steroids for 2 weeks.I am fully active and can carry on all my pre-disease activities without restriction.I have a hormone disorder caused by my pituitary gland.I haven't had vaccines for infectious diseases in the last 4 weeks.I have tested positive for HIV/AIDS.My liver function tests are within the required range.I haven't had cancer treatment like radiation or chemotherapy in the last 2 weeks.I have cancer cells in the fluid around my brain and spinal cord.I am on immunosuppressive therapy or I am HIV positive.I have Crohn's disease or ulcerative colitis.I have heart failure or had a recent heart problem.I have (not) been treated before, depending on the study phase I am entering.My blood, kidney, or liver tests are not within the normal range.I understand the study's risks and have signed the consent form.I am willing and able to follow the study's procedures and be available for its duration.My skin condition covers 25% or more of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you illustrate the research conducted on Trabectedin to date?
"Currently, there are 779 active studies being conducted on Trabectedin with 88 of them in the third phase. These clinical trials are largely centered around Pittsburgh, Pennsylvania but can be found at 42897 centres worldwide."
Answered by AI
How extensive is the current participant pool for this experiment?
"Correct. According to clinicaltrials.gov, the experimental trial commencing on April 13th 2017 is currently recruiting participants and requires 45 people from a single location for completion."
Answered by AI
Are there any vacancies available within this research project?
"The data presented on clinicaltrials.gov indicates that this medical experiment is in its active recruitment phase, having initially been posted on April 13th 2017 and most recently updated on May 4th 2022."
Answered by AI
What maladies is Trabectedin typically prescribed for?
"Trabectedin is typically used to treat inoperable melanoma, but it can also be prescribed for squamous cell carcinoma and a heightened risk of recurrence."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger