Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Experimental combo targets Hard-to-Treat cancers

NCT ID NCT03085225

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-phase trial tested the combination of two drugs—trabectedin and durvalumab—in 40 people with advanced soft-tissue sarcoma or ovarian cancer that had not responded to prior treatments. The main goal was to find a safe dose and check for side effects. Researchers also looked for early signs of tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trabectedin and durvalumab
What this could lead to
If successful, this could point toward a new combination treatment for advanced soft-tissue sarcoma and ovarian cancer.
What could go wrong
This is a very early phase 1 trial with only 40 participants, focused on safety and dosing. It is too small to prove effectiveness, and the combination may cause significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

40 people

The number who actually took part.

Started

May 2017

Finished

Jan 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histology : * Soft-tissue sarcoma histologically confirmed. In care outside a center of the RRePS Network, a central review is necessary (Pr. Coindre team), * histologically confirmed ovarian carcinoma (carcinosarcoma included), or ovarian carcinoma without known g/s BRCA mutation 2. Ovarian carcinoma must have received at least one line of platinum-containing regimen 3. Metastatic or unresectable locally advanced disease, not amenable to curative therapy 4. Age ≥ 18 years, 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1, 6. Life expectancy \> 3 months, 7. Patients must have measurable disease (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST 1.1) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as \> 10 mm with spiral CT scan. 8. Documented disease progression according to RECIST v1.1 before study entry, 9. Patient must comply with the collection of tumor biopsies, 10. At least 1 line of chemotherapy in the palliative setting with use of Anthracyclines (for STS), 11. At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy, 12. Adequate hematological, renal, metabolic and hepatic function: 1. Hemoglobin ≥ 9 g/dl (patients may have received prior red blood cell \[RBC\] transfusion, if clinically indicated); absolute neutrophil count (ANC) ≥ 1.5 x 109/l, and platelet count ≥ 100 x 109/l. 2. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normality (ULN) (≤ 5 in case of extensive liver involvement) and alkaline phosphatase (AP) ≤ 2.5 x ULN. 3. Total bilirubin ≤ ULN. 4. Albumin ≥ 25 g/l. 5. Calculated creatinine clearance (CrCl) \> 60 ml/min (according to Cockroft Gault formula). 6. Thyroid function within normal laboratory ranges (TSH, free T3, free T4). 7. Creatine Phosphokinase (CPK) ≤ 2.5 x ULN 13. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of trial medication. Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for six months after discontinuation of treatment. 14. No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma, 15. Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment (excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0), 16. Voluntarily signed and dated written informed consent prior to any study specific procedure, 17. Patients with a social security in compliance with the French law . Exclusion Criteria: 1. Previous treatment with Trabectedin or an anti-PD-1, anti-PD-L1, anti-PD-L2, including durvalumab 2. Current or prior use of immunosuppressive medication medication including any use of oral glucocorticoids, within 21 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses 3. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), 4. Has an active autoimmune disease requiring systemic treatment within the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insuddiciency) is not considered a form of systemic treatment, 5. Has evidence of active non-infectious pneumonitis, 6. Has an active infection requiring systemic therapy, 7. Currently active bacterial or fungus infection (\> grade 2 CTC \[CTCAE\] HIV1, HIV2, hepatitis A or hepatitis B or hepatitis C infections, 8. Known central nervous system malignancy (CNS), 9. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding, 10. Previous enrolment in the present study, 11. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons, 12. Has received a live vaccine within 30 days prior to the first dose of trial treatment. Note: the killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. 13. Known hypersensitivity to any involved study drug or any of its formulation components, 14. Tumors not accessible for biopsy, 15. Known history of active tuberculosis 16. Person under judicial protection or deprived of liberty, 17. Cardiac dysfunction: LVEF \< 40% at Baseline or clinically symptomatic cardiac dysfunction (any % of LVEF at Baseline) 18. Concomitant use of strong inhibitor or inductors of cytochrome CYP3A4 taken within 21 days prior to the first dose of study drug

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Ovarian carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centre Léon Bérard

    Lyon, 69373, France

  • Institut Bergonié

    Bordeaux, 33076, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.