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Alkylating agents
Lurbinectedin + Immunotherapy for Soft Tissue Sarcoma (LINNOVATE Trial)
Phase 1 & 2
Recruiting
Led By Erlinda M Gordon, MD
Research Sponsored by ERLINDA M GORDON
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a potential cancer treatment using three drugs given intravenously in increasing doses.
Who is the study for?
Adults over 18 with advanced soft tissue sarcoma, either previously treated (for Phase 1) or untreated (for Phase 2), can join this trial. They must have measurable disease, good blood counts and organ function, understand the study risks, consent in writing, be willing to follow procedures for the study's duration, use effective contraception, and have a life expectancy of at least 3 months. Those with certain health conditions or treatments are excluded.
What is being tested?
The LINNOVATE trial is testing different doses of Lurbinectedin given through IV along with set doses of Ipilimumab and Nivolumab also administered via IV. It's an open-label phase 1/2 study which means everyone knows what treatment they're getting and there are two parts: dose-finding followed by effectiveness testing.
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever or chills; immune-related issues like inflammation in organs; fatigue; changes in liver enzymes; skin rash; hormonal imbalances; gastrointestinal problems like diarrhea or colitis; increased risk of infection due to immunosuppression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
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
Correlation of response with circulating tumor DNA
Objective response rate
Overall survival
+1 moreAwards & 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 1/2 study using lurbinectedin, ipilimumab and nivolumab for advanced soft tissue sarcomaExperimental Treatment1 Intervention
This is an open label, dose-seeking phase 1/2 study using escalating doses of LURBINECTEDIN administered intravenously with fixed doses of IPILIMUMAB and NIVOLUMAB administered intravenously.
I. Dose Escalation Phase 1 of Study: The study will employ the standard "cohort of three" design (Storer, 1989).
II.Phase 2 of Study: Following completion of dose escalation, an additional 28-34 previously untreated participants will receive LURBINECTEDIN at the MTD and fixed doses of IPILIMUMAB and NIVOLUMAB to assess overall safety and potential efficacy in a larger number of participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lurbinectedin
2022
Completed Phase 3
~780
Find a Location
Who is running the clinical trial?
ERLINDA M GORDONLead Sponsor
Erlinda M Gordon, MDPrincipal InvestigatorSarcoma Oncology Research Center
3 Previous Clinical Trials
79 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had vaccines for infectious diseases in the last 4 weeks.I am on immunosuppressive therapy or I am HIV positive.I have not had ongoing or uncontrolled diarrhea in the last 4 weeks.I haven't had cancer treatment like radiation or chemotherapy in the last 3 weeks.I am unable or unwilling to follow the study rules.I have an autoimmune disease like rheumatoid arthritis or lupus.I have heart failure or had a recent heart problem.I have a condition affecting my adrenal glands.My brain metastases are treated, and I've been stable without steroids for 2 weeks.I haven't had recent severe gut issues like diverticulitis or blockages.I am 18 years old or older.My sarcoma cannot be surgically removed and has spread.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 have cancer cells in the fluid around my brain and spinal cord.I have received immunotherapy targeting CTLA4 or PD-1.I have (not) been treated before and am interested in Phase 1 (Phase 2) of the study.My blood counts are within normal ranges without needing help from medications or transfusions recently.My skin condition affects more than a quarter of my body.I have inflammatory bowel disease (Crohn's or ulcerative colitis).I understand the study's risks and have signed the consent form.I am not pregnant or breastfeeding.My kidney function is within the normal range.My liver functions within normal limits, or close to it, even if I have liver metastases.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1/2 study using lurbinectedin, ipilimumab and nivolumab for advanced soft tissue sarcoma
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.
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