Ovarian CarcinomaPhase 1TRAMUNENCT03085225
Trabectedin Combined With Durvalumab in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas.
A Phase 1 study testing Combination of trabectedin with durvalumab in people with Ovarian Carcinoma and Soft Tissue Sarcoma, run by Institut Bergonié at 2 sites in France.
Trial summary
A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Carcinoma, Soft Tissue Sarcoma
- What is being tested?
- Combination of trabectedin with durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 5 May 2017to 4 Jan 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Ovarian carcinoma must have received at least one line of platinum-containing regimen
- Metastatic or unresectable locally advanced disease, not amenable to curative therapy
- Age ≥ 18 years,
Show all 26Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
- Life expectancy > 3 months,
- 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.
- Documented disease progression according to RECIST v1.1 before study entry,
- Patient must comply with the collection of tumor biopsies,
- At least 1 line of chemotherapy in the palliative setting with use of Anthracyclines (for STS),
- At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy,
- Adequate hematological, renal, metabolic and hepatic function:
- 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.
- 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.
- Total bilirubin ≤ ULN.
- Albumin ≥ 25 g/l.
- Calculated creatinine clearance (CrCl) > 60 ml/min (according to Cockroft Gault formula).
- Thyroid function within normal laboratory ranges (TSH, free T3, free T4).
- Creatine Phosphokinase (CPK) ≤ 2.5 x ULN
- 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.
- 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,
- 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),
- Voluntarily signed and dated written informed consent prior to any study specific procedure,
- Patients with a social security in compliance with the French law .
Who cannot join
- Previous treatment with Trabectedin or an anti-PD-1, anti-PD-L1, anti-PD-L2, including durvalumab
- 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
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis),
- 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,
- Has evidence of active non-infectious pneumonitis,
- Has an active infection requiring systemic therapy,
Show all 19Show fewer
- Currently active bacterial or fungus infection (> grade 2 CTC [CTCAE] HIV1, HIV2, hepatitis A or hepatitis B or hepatitis C infections,
- Known central nervous system malignancy (CNS),
- 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,
- Previous enrolment in the present study,
- Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
- 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.
- Known hypersensitivity to any involved study drug or any of its formulation components,
- Tumors not accessible for biopsy,
- Known history of active tuberculosis
- Person under judicial protection or deprived of liberty,
- Cardiac dysfunction: LVEF < 40% at Baseline or clinically symptomatic cardiac dysfunction (any % of LVEF at Baseline)
- Concomitant use of strong inhibitor or inductors of cytochrome CYP3A4 taken within 21 days prior to the first dose of study drug
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Trabectedin Combined With Durvalumab (MEDI4736) in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas. A Phase Ib Study.
A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas.
Read the detailed description
This is a multicenter, prospective phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing three dose levels of Trabectedin given with durvalumab, followed by two expansion cohorts once the MTD is established.
- Conditions
- Ovarian Carcinoma, Soft Tissue Sarcoma
- Being tested
- Combination of trabectedin with durvalumab
- Keywords
- Advanced tumor, Pretreated tumor, Soft Tissue Sarcomas, Ovarian Carcinomas, Phase Ib, Circulating DNA
- Medical subject headings
- Ovarian Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of trabectedin with durvalumabDrug
Dose Escalation : 3 doses of trabectedin given in combination with durvalumab (fixed dose) will be investigated.
A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.).
Expansion cohorts: Once the Maximum Tolerated Dose (MTD) has been defined, the expansion cohorts will be opened. All patients will be treated at the MTD of Trabectedin (as defined in the dose escalation part of the trial) given in association with Durvalumab with the same schedule as in the dose escalation part of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Combination of trabectedin with durvalumab | Experimental | Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.
Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks. Receives: Drug: Combination of trabectedin with durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Part: Establish the Recommended Phase II Dose (RP2D), the Maximum Tolerated Dose (MTD) Evaluated on the First Cycle (D1 to D21), the Safety Profile, and the Dose Limiting Toxicities (DLT) of Trabectedin Given in Combination With Durvalumab
A DLT is defined as an AE or laboratory abnormality that fulfills all the criteria below:
- Begins on the first 21 days of treatment.
- Is considered to be at least possibly related to the study treatment.
- Meets one of the criteria below, graded as outlined or according to NCI-CTCAEv4.03 :
- Any grade-4 toxicity (except for vomiting without maximal symptomatic/prophylactic treatment and if toxicity is transaminitis, but which have to be resolved at Day 21, i.e. return to Baseline or grade 1).
- Grade-3 non-haematological toxicity lasting > 7days.
- Grade-3 hematologic toxicity lasting for > 7days.
- Grade 4 neutropenia with fever.
- Grade > 2 thrombocytopenia with bleeding.
Endpoints:
- Toxicity graded using the common toxicity criteria from the the NCI-CTCAE v4.03.
- Incidence rate of DLT at each dose level during the first 21 days.
Measured: During the first cycle (21 days)
Expansion Cohorts : Evaluate Preliminary Signs of the Antitumor Activity of Trabectedin Given in Combination With Durvalumab in Terms of Objective Response Under Treatment.
Following RECIST v1.1 recommendations:
- Objective response rate (ORR) is defined as the proportion of patients with complete or partial response (CR, PR) as per RECIST v1.1 criteria.
- Objective response under treatment is recorded from study treatment initiation until the end of treatment and determined once all the data for the patient is known.
- Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
- Disease status under treatment, whatever the response observed, will be centrally reviewed for all patients, by an independent expert radiologist. Reviewed data will be used for the efficacy analysis.
Measured: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 5.1 months
Secondary outcomes (10)
Dose Escalation Part: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation as per RECIST v1.1 criteria:
Following RECIST v1.1 recommendations:
- The best overall response is determined once all the data for the patient is known.
- Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Measured: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 5.1 months
Dose Escalation Part : Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response according to RECIST v1.1 criteria. ORR under treatment and 6-month ORR will be reported ORR under treatment is recorded from study treatment initiation until the end of treatment. Following RECIST v1.1 recommendations:
- ORR under treatment is determined once all the data for the patient is known.
- Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Measured: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, an average of 5.1 months and ORR at 6-month
Dose Escalation Part : Progression-free Rate (PFR) at 6-month
Progression-free rate (PFR) is defined as the proportion of patients with complete response, partial response or stable disease more than 24 weeks as defined as per RECIST v1.1 criteria. 6-month PFR will be reported. Following RECIST v1.1 recommendations, claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Measured: 6-month progression-free Rate (PFR) as per RECIST v1.1
Dose Escalation Part : 1-year Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. 1-year PFS rate will be reported.
Measured: 1-year progression-free survival (PFS) rate as per RECIST v1.1
Dose Escalation Part : 1-year Overall Survival (OS)
Overall Survival (OS) is defined as the time from study treatment initiation to death (of any cause). 1-year OS rate will be reported.
Measured: 1-year Overall Survival (OS) as per RECIST v1.1
Expansion Cohorts: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation as per RECIST v1.1 criteria:
Following RECIST v1.1 recommendations:
The best overall response is determined once all the data for the patient is known.
Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Measured: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 5.1 months
Expansion Cohorts : 6-month Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients with complete response or partial response according to RECIST v1.1 criteria. 6-month ORR will be reported. Following RECIST v1.1 recommendations: Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Measured: 6-month Objective response rate (ORR) as per RECIST v1.1
Expansion Cohorts: 6-month Progression-free Rate (PFR)
Progression-free rate (PFR) is defined as the proportion of patients with complete response, partial response or stable disease more than 24 weeks as defined as per RECIST v1.1 criteria. 6-month PFR will be reported. . Following RECIST v1.1 recommendations, claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors.
Measured: 6-month progression-free rate (PFR) as per RECIST v1.1
Expansion Cohorts: 1-year Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first. 1-year PFS rate will be reported.
Measured: 1-year Progression-free survival (PFS) as per RECIST v1.1
Expansion Cohort : 1-year Overall Survival (OS)
Overall Survival (OS) is defined as the time from study treatment initiation to death (of any cause). 1-year OS rate will be reported.
Measured: 1-year Overall Survival (OS) as per RECIST v1.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start5 May 2017
- Primary completion19 Nov 2020
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multicenter, prospective open-labeled phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing three dose levels of trabectedin when prescribed in combination with durvalumab followed by two expansion cohorts (Soft-tissue sarcomas and ovarian carcinomas) once the MTD is established
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, PharmaMar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085225
- Sponsor's protocol ID
- IB2016-02
- Acronym
- TRAMUNE
- Status last verified
- Sep 2025
- First submitted
- 15 Mar 2017
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trabectedin Combined With Durvalumab (MEDI4736) in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas. A Phase Ib Study.
- ClinicalTrials.gov ID
- NCT03085225
- Acronym / sponsor ID
- TRAMUNE / IB2016-02
- Conditions
- Ovarian Carcinoma, Soft Tissue Sarcoma
- Keywords
- Advanced tumor, Pretreated tumor, Soft Tissue Sarcomas, Ovarian Carcinomas, Phase Ib, Circulating DNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- AstraZeneca, PharmaMar
- Study start
- 5 May 2017 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas.
Detailed description
This is a multicenter, prospective phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing three dose levels of Trabectedin given with durvalumab, followed by two expansion cohorts once the MTD is established.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multicenter, prospective open-labeled phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing three dose levels of trabectedin when prescribed in combination with durvalumab followed by two expansion cohorts (Soft-tissue sarcomas and ovarian carcinomas) once the MTD is established
| Arm | Type | Receives |
|---|---|---|
| Combination of trabectedin with durvalumab | Experimental | Drug: Combination of trabectedin with durvalumabTrabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level. Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Histology :
- Ovarian carcinoma must have received at least one line of platinum-containing regimen
- Metastatic or unresectable locally advanced disease, not amenable to curative therapy
- Age ≥ 18 years,
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
Key exclusion criteria (19 listed)
- Previous treatment with Trabectedin or an anti-PD-1, anti-PD-L1, anti-PD-L2, including durvalumab
- 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
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis),
- 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,
- Has evidence of active non-infectious pneumonitis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of trabectedin with durvalumabDose Escalation : 3 doses of trabectedin given in combination with durvalumab (fixed dose) will be investigated. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.). Expansion cohorts: Once the Maximum Tolerated Dose (MTD) has been defined, the expansion cohorts will be opened. All patients will be treated at the MTD of Trabectedin (as defined in the dose escalation part of the trial) given in association with Durvalumab with the same schedule as in the dose escalation part of the trial. | Drug | Combination of trabectedin with durvalumab |
Primary outcome
Dose Escalation Part: Establish the Recommended Phase II Dose (RP2D), the Maximum Tolerated Dose (MTD) Evaluated on the First Cycle (D1 to D21), the Safety Profile, and the Dose Limiting Toxicities (DLT) of Trabectedin Given in Combination With Durvalumab
Time frame: During the first cycle (21 days)
A DLT is defined as an AE or laboratory abnormality that fulfills all the criteria below: * Begins on the first 21 days of treatment. * Is considered to be at least possibly related to the study treatment. * Meets one of the criteria below, graded as outlined or according to NCI-CTCAEv4.03 : * Any grade-4 toxicity (except for vomiting without maximal symptomatic/prophylactic treatment and if toxicity is transaminitis, but which have to be resolved at Day 21, i.e. return to Baseline or grade 1). * Grade-3 non-haematological toxicity lasting > 7days. * Grade-3 hematologic toxicity lasting for > 7days. * Grade 4 neutropenia with fever. * Grade > 2 thrombocytopenia with bleeding. Endpoints: * Toxicity graded using the common toxicity criteria from the the NCI-CTCAE v4.03. * Incidence rate of DLT at each dose level during the first 21 days.
Expansion Cohorts : Evaluate Preliminary Signs of the Antitumor Activity of Trabectedin Given in Combination With Durvalumab in Terms of Objective Response Under Treatment.
Time frame: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 5.1 months
Following RECIST v1.1 recommendations: * Objective response rate (ORR) is defined as the proportion of patients with complete or partial response (CR, PR) as per RECIST v1.1 criteria. * Objective response under treatment is recorded from study treatment initiation until the end of treatment and determined once all the data for the patient is known. * Claimed responses will have to be confirmed at least 4 weeks later to ensure responses identified are not the result of measurement errors. * Disease status under treatment, whatever the response observed, will be centrally reviewed for all patients, by an independent expert radiologist. Reviewed data will be used for the efficacy analysis.
10 secondary outcomes
Dose Escalation Part: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Time frame: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 5.1 months
Dose Escalation Part : Objective Response Rate (ORR)
Time frame: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, an average of 5.1 months and ORR at 6-month
Dose Escalation Part : Progression-free Rate (PFR) at 6-month
Time frame: 6-month progression-free Rate (PFR) as per RECIST v1.1
Dose Escalation Part : 1-year Progression-free Survival (PFS)
Time frame: 1-year progression-free survival (PFS) rate as per RECIST v1.1
Dose Escalation Part : 1-year Overall Survival (OS)
Time frame: 1-year Overall Survival (OS) as per RECIST v1.1
Expansion Cohorts: Preliminary Signs of Antitumor Activity, Best Overall Response (BOR)
Time frame: Tumor assessment were repeated every 8 weeks (±7 days, i.e Week 8, 16, 24, etc.) from the start of treatment and at least 4 weeks after the first CR or PR, even if there are treatment delays, an average of 5.1 months
Expansion Cohorts : 6-month Objective Response Rate (ORR)
Time frame: 6-month Objective response rate (ORR) as per RECIST v1.1
Expansion Cohorts: 6-month Progression-free Rate (PFR)
Time frame: 6-month progression-free rate (PFR) as per RECIST v1.1
Expansion Cohorts: 1-year Progression-free Survival (PFS)
Time frame: 1-year Progression-free survival (PFS) as per RECIST v1.1
Expansion Cohort : 1-year Overall Survival (OS)
Time frame: 1-year Overall Survival (OS) as per RECIST v1.1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combination of trabectedin with durvalumab in people with Ovarian Carcinoma and Soft Tissue Sarcoma, run by Institut Bergonié at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Part: Establish the Recommended Phase II Dose (RP2D), the Maximum Tolerated Dose (MTD) Evaluated on the First Cycle (D1 to D21), the Safety Profile, and the Dose Limiting Toxicities (DLT) of Trabectedin Given in Combination With Durvalumab (time frame: During the first cycle (21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.