RECRUITING

LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

LINNOVATE: A Phase 1/2 Study of Safety/Efficacy Using LURBINECTEDIN, Combined With IPILIMUMAB, and NIVOLUMAB for Advanced Soft Tissue Sarcomas

Quick Facts

Study Start:2023-06-07

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05876715

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or Female ≥ 18 years of age 2. Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma 3. For the Phase 1 Part of Study, only previously treated participants will be enrolled. For the Phase 2 Part of Study, previously untreated participants will be enrolled. 4. Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the principal investigator's IRB/Ethics Committee 5. Willingness to comply with all study procedures and availability for the duration of the study. 6. Measurable disease by RECIST v1.1 7. ECOG performance status ≤ 1 8. Life expectancy of at least 3 months 1. Acceptable liver function: Bilirubin \< 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \< 3.0 ULN); 2. AST (SGOT), ALT (SGPT) and alkaline phosphatase \< 3 x ULN (\< 5 x ULN if liver metastases) 3. Acceptable renal function: Creatinine \< 1.5 times ULN or \> 60 mL/min (using the Cockcroft Gault formula) 9. Acceptable hematologic status (without hematologic support e.g. growth factors or transfusion within 21 days of first dose of study agents): ANC \>= 1500 cells/μL; Platelet count \>= 100,000/μL; Hemoglobin \>= 9.0 g/dL; Normal PT, PTT, INR 10. All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.	1. Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of \<10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation. 2. Subjects with carcinomatous meningitis 3. Anticancer treatment with radiation therapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry. Anticancer treatment with chemotherapy within 21 days prior to study entry. 4. Subjects who participated in an investigational drug or device study within 14 days prior to study entry 5. Females who are pregnant or breast-feeding 6. Unwillingness or inability to comply with the study protocol for any reason 7. Concurrent or prior immunotherapy with anti-CTLA4 or anti-PD-1 inhibitors 8. Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks of trial enrollment 9. Autoimmune disease including rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis and motor neuropathy considered to be of autoimmune origin (e.g. Guillain-Barre Syndrome) 10. Systemic immunosuppression, including HIV positive status with or without AIDS 11. Skin rash (psoriasis, eczema) affecting \> 25% body surface area 12. Inflammatory bowel disease (Crohn's or ulcerative colitis) 13. Ongoing or uncontrolled diarrhea within 4 weeks of trial enrollment 14. Recent history of acute diverticulitis, intraabdominal abscess or gastrointestinal obstruction within 6 months of trial enrollment, which are known risk factors for bowel perforation 15. Participants with congestive heart failure or recent cardiac event 16. Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, which in the principal investigator or sub-investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the trial 17. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection 18. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 19. Current, active, or previous history of heavy alcohol abuse 20. Pituitary endocrinopathy 21. Adrenal insufficiency or excess

Inclusion Criteria

Exclusion Criteria

1. Male or Female ≥ 18 years of age
2. Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma
3. For the Phase 1 Part of Study, only previously treated participants will be enrolled. For the Phase 2 Part of Study, previously untreated participants will be enrolled.
4. Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the principal investigator's IRB/Ethics Committee
5. Willingness to comply with all study procedures and availability for the duration of the study.
6. Measurable disease by RECIST v1.1
7. ECOG performance status ≤ 1
8. Life expectancy of at least 3 months
1. Acceptable liver function: Bilirubin \< 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \< 3.0 ULN);
2. AST (SGOT), ALT (SGPT) and alkaline phosphatase \< 3 x ULN (\< 5 x ULN if liver metastases)
3. Acceptable renal function: Creatinine \< 1.5 times ULN or \> 60 mL/min (using the Cockcroft Gault formula)
9. Acceptable hematologic status (without hematologic support e.g. growth factors or transfusion within 21 days of first dose of study agents): ANC \>= 1500 cells/μL; Platelet count \>= 100,000/μL; Hemoglobin \>= 9.0 g/dL; Normal PT, PTT, INR
10. All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.

1. Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of \<10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.
2. Subjects with carcinomatous meningitis
3. Anticancer treatment with radiation therapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry. Anticancer treatment with chemotherapy within 21 days prior to study entry.
4. Subjects who participated in an investigational drug or device study within 14 days prior to study entry
5. Females who are pregnant or breast-feeding
6. Unwillingness or inability to comply with the study protocol for any reason
7. Concurrent or prior immunotherapy with anti-CTLA4 or anti-PD-1 inhibitors
8. Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks of trial enrollment
9. Autoimmune disease including rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis and motor neuropathy considered to be of autoimmune origin (e.g. Guillain-Barre Syndrome)
10. Systemic immunosuppression, including HIV positive status with or without AIDS
11. Skin rash (psoriasis, eczema) affecting \> 25% body surface area
12. Inflammatory bowel disease (Crohn's or ulcerative colitis)
13. Ongoing or uncontrolled diarrhea within 4 weeks of trial enrollment
14. Recent history of acute diverticulitis, intraabdominal abscess or gastrointestinal obstruction within 6 months of trial enrollment, which are known risk factors for bowel perforation
15. Participants with congestive heart failure or recent cardiac event
16. Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, which in the principal investigator or sub-investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the trial
17. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
18. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
19. Current, active, or previous history of heavy alcohol abuse
20. Pituitary endocrinopathy
21. Adrenal insufficiency or excess

Contacts and Locations

Study Contact

Erlinda M Gordon, MD

CONTACT

310-552-9999

egordon@sarcomaoncology.com

Victoria Chua-Alcala, MD

CONTACT

310-552-9999

vchua@sarcomaoncology.com

Principal Investigator

Erlinda M Gordon, MD

PRINCIPAL_INVESTIGATOR

Sarcoma Oncology Research Center

Study Locations (Sites)

Sarcoma Oncology Research Center

Santa Monica, California, 90403

United States

Collaborators and Investigators

Sponsor: ERLINDA M GORDON

Erlinda M Gordon, MD, PRINCIPAL_INVESTIGATOR, Sarcoma Oncology Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-07

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-06-07

Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

Advanced Soft-tissue Sarcoma