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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| PharmaMar | INDUSTRY |
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A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of trabectedin with durvalumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Endpoints:
| 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
Inclusion Criteria:
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,
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:
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 .
Exclusion Criteria:
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,
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33076 | France | |||
| Centre Léon Bérard |
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40 patients were included of the study from October 19th 2017 to November 6th 2019.
Inclusions were carried out in two French centers : Institut Bergonié, Bordeaux and Centre Léon Bérard, Lyon
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation (Trabectedin Dose Level 1,0 mg/m²) | 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. |
| FG001 | Dose Escalation (Trabectedin Dose Level 1,2 mg/m²) | 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. |
| FG002 | Expansion Cohort - Soft-tissue Sarcoma (STS) | 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. |
| FG003 | Expansion Cohort - Ovarian Carcinomas (OV) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Eligible population: population without major deviation regarding inclusion/exclusion criteria and conduct of the study
Efficacy population (expansion cohorts only): population eligible and assessable for primary and secondary efficacy endpoints
Safety population:
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation (Trabectedin Dose Level 1,0 mg/m²) | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
Endpoints:
| The following patients will not be included in the population assessable for safety (primary analysis) and thus will be replaced:
| Posted | Number | Number of DLTs |
Monitored every 28 days during treatment consultation and up to 30 days after the last treatment administration or until the start of a new antitumor therapy. All SAEs occurring within 90 days of the last treatment administration or until the start of a new antitumor therapy were reported. After treatment discontinuation, patients were followed up 4 weeks later for toxicities. Grade 3 or 4 toxicity were monitored until resolution, through study completion, an average of 16 months.
Safety population: All patients having received at least one treatment administration.
All adverse events (related and unrelated to treatment) are reported. All serious adverse events (related and unrelated to treatment) are reported.
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Escalation (Trabectedin Dose Level 1,0 mg/m²) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Simone Mathoulin-Pelissier | Institut Bergonié | 0556333333 | S.Mathoulin@bordeaux.unicancer.fr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2021 | Apr 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2019 | Apr 5, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
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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
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Open Label
Not provided
|
| 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:
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1-year Overall Survival (OS) as per RECIST v1.1 |
| Lyon |
| 69373 |
| France |
| Dose Escalation (Trabectedin Dose Level 1,2 mg/m²) |
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. |
| BG002 | Expansion Cohort - Soft-tissue Sarcoma (STS) | 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. |
| BG003 | Expansion Cohort - Ovarian Carcinomas (OV) | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ECOG | Eastern Cooperative Oncology Group (ECOG) performance status (PS) with a scale from 0 to 4; Grade 0 : Able to carry on all normal activities without restriction. Grade 1 : Restricted in physically strenuous activity but ambulatory and able to carry out light work. Any ECOG grade > 1 is considered as worse outcome. | Count of Participants | Participants |
|
| During the first cycle (21 days) |
|
|
|
| Primary | 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:
| Population assessable for efficacy: All patients eligible and for whom the following conditions are statisfied:
| Posted | Number | Participants | 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 | 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:
| Posted | Count of Participants | Participants | 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 | 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:
| Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6-month progression-free Rate (PFR) as per RECIST v1.1 |
|
|
|
| Secondary | 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. | Given the small sample size in each arm (3 patients in the arm "Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)" and 6 patients in the arm "Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)", we had pre-specified to combine these 2 arms, regardless of dose administered, for the calculation of "Dose Escalation Part : 1-year Progression-free Survival (PFS). | Posted | Number | 95% Confidence Interval | percentage of participants | 1-year progression-free survival (PFS) rate as per RECIST v1.1 |
|
|
|
| Secondary | 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. | Given the small sample size in each arm (3 patients in the arm "Dose Escalation (Trabectedin Dose Level 1,0 mg/m²)" and 6 patients in the arm "Dose Escalation (Trabectedin Dose Level 1,2 mg/m²)", we had pre-specified to combine these 2 arms, regardless of dose administered, for the calculation of "Dose Escalation Part : 1-year Overall Survival (OS)". | Posted | Number | 95% Confidence Interval | percentage of participants | 1-year Overall Survival (OS) as per RECIST v1.1 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 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 | 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. | Posted | Count of Participants | Participants | 6-month Objective response rate (ORR) as per RECIST v1.1 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6-month progression-free rate (PFR) as per RECIST v1.1 |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 1-year Progression-free survival (PFS) as per RECIST v1.1 |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 1-year Overall Survival (OS) as per RECIST v1.1 |
|
|
|
| 1 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Dose Escalation (Trabectedin Dose Level 1,2 mg/m²) | 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. | 3 | 6 | 3 | 6 | 6 | 6 |
| EG002 | Expansion Cohort - Soft-tissue Sarcoma (STS) | 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. | 8 | 16 | 9 | 16 | 16 | 16 |
| EG003 | Expansion Cohort - Ovarian Carcinomas (OV) | 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. | 9 | 14 | 7 | 14 | 14 | 14 |
| Non cardiac-chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Device related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Left ventricular systolic dysfunction | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| DEGRADATION OF GENERAL STATUS | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| PROGRESSIVE DISEASE | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| SUBOCCLUSIVE SYNDROME | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| CPK increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysesthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| CHALAZION | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| GLAIRY STOOLS | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| OCCLUSIVE SYNDROME | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| STOOL DISCOLORATION | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| SUB OCCLUSIVE SYNDROMA | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aphtosis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| GGT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone marrow hypocellular | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bronchial infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Enterocolitis infectious | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| COLD | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| COVID 19 SYMPTOMS | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| LDH INCREASE | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| TSH INCREASE | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lipase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| STIFFNESS | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| CRAMPS | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| HAND CRAMP | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| MUSCLE CRAMPS | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| HEPATIC KYST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| TINGLING HANDS | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| LEFT LATERAL EPICONDYLITIS | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Prostatic pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| TEMPO-SPATIAL DISORIENTATION | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| NOSE PAIN AND SCABS | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| BRONCHITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| HEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rhinitis infective | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| ECZEMA ERUPTION | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| FACE'S CUTANEOUS RASH | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal inflammation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Vasovagal reaction | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| PSYCHOMOTOR RETARDATION | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| ECOG=1 |
|
| Progressive disease |
|
| Progressive disease |
|
| Not evaluable |
|