NCT02825420: NIMES-ROC

Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients

Completed Results posted Last updated 29 October 2021

What this trial tests

trial testing trabectedin in Relapsed Ovarian Cancer in 220 participants. Completed in 18 September 2019.

Timeline

28 July 2015

Primary endpoint
18 September 2019

18 September 2019

Quick facts

Lead sponsor	PharmaMar
Status	Completed
Study type	OBSERVATIONAL
Enrollment	220
Start date	28 July 2015
Primary completion	18 September 2019
Estimated completion	18 September 2019
Sites	65 locations across France, Italy, Belgium, Germany, Spain

Drugs / interventions tested

• trabectedin (TRABECTEDIN) — full drug profile →

Conditions studied

• Relapsed Ovarian Cancer — all drugs for Relapsed Ovarian Cancer →

Sponsor

PharmaMar — full company profile →

Who can join

18 and older, female only, with Relapsed Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-Free Survival Primary · From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)

PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD o

Group	Value	95% CI
Full Analysis Set	9.46	7.9 – 10.9

Progression Free Survival by Prior Antiangiogenic Treatment Primary · From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)

PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD o

Group	Value	95% CI
Prior Use of Antiangiogenics	7.59	6.4 – 10.0
No Prior Use of Antiangiogenics	12.45	9.4 – 14.3

Progression Free Survival by BRCA1/2 Status Primary · From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)

PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD o

Group	Value	95% CI
Positive BRCA	9.23	6.0 – 17.1
Negative	8.97	7.1 – 10.3

Progression Free Survival by Platinum Sensitivity Primary · From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)

PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD o

Group	Value	95% CI
Fully Platinum Sensitivity	9.26	7.1 – 12.5
Partially Platinum Sensitivity	9.46	7.4 – 11.4

Best Tumor Response Secondary · From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)

Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Group	Value	95% CI
Full Analysis Set	24
Full Analysis Set	57
Full Analysis Set	59
Full Analysis Set	62

Best Response by Prior Antiangiogenic Treatment Secondary · From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)

Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Group	Value	95% CI
Prior Use of Antiangiogenics	46
No Prior Use of Antiangiogenics	16
Prior Use of Antiangiogenics	32
No Prior Use of Antiangiogenics	27
Prior Use of Antiangiogenics	27
No Prior Use of Antiangiogenics	30
Prior Use of Antiangiogenics	11
No Prior Use of Antiangiogenics	13

Overall Survival Secondary · From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)

Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.

Group	Value	95% CI
Full Analysis Set	23.56	18.1 – 34.1

Overall Survival by Prior Antiangiogenic Treatment Secondary · From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)

Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.

Group	Value	95% CI
Prior Use of Antiangiogenics	21.85	16.7 – 39.6
No Prior Use of Antiangiogenics	26.28	18.1 – 40.1

Overall Survival by BRCA1/2 Status Secondary · From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)

Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.

Group	Value	95% CI
Positive BRCA	23.56	16.1 – 40.1
Negative	21.85	16.7 – NA

Overall Survival by Platinum Sensitivity Secondary · From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)

Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.

Group	Value	95% CI
Fully Platinum Sensitivity	23.56	16.7 – 34.1
Partially Platinum Sensitivity	26.05	17.7 – 39.6

Change From Baseline to Best Post-baseline ECOG Performance Status Score Secondary · Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)

Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead

Group	Value	95% CI
Full Analysis Set	24
Full Analysis Set	125
Full Analysis Set	14
Full Analysis Set	55

Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment Secondary · Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)

Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead

Group	Value	95% CI
Prior Use of Antiangiogenics	14
No Prior Use of Antiangiogenics	10
Prior Use of Antiangiogenics	83
No Prior Use of Antiangiogenics	42
Prior Use of Antiangiogenics	5
No Prior Use of Antiangiogenics	9
Prior Use of Antiangiogenics	27
No Prior Use of Antiangiogenics	28

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prior Use of Antiangiogenics

Serious: 23/129 (18%)

Deaths: 30/129

No Prior Use of Antiangiogenics

Serious: 14/89 (16%)

Deaths: 12/89

Serious adverse events (54 terms)

Reaction	System	Prior Use of Antiangiogenics	No Prior Use of Antiangiog…
Neutropenia	Blood and lymphatic system disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—
Pyrexia	General disorders	—	—
Pneumonia	Infections and infestations	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Gastrointestinal obstruction	Gastrointestinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Oesophagitis	Gastrointestinal disorders	—	—
Retching	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Enteritis	Gastrointestinal disorders	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Disease progression	General disorders	—	—
Fatigue	General disorders	—	—
Oedema	General disorders	—	—

Other adverse events (16 terms — click to expand)

Reaction	System	Prior Use of Antiangiogenics	No Prior Use of Antiangiog…
Neutropenia	Blood and lymphatic system disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Leukopenia	Blood and lymphatic system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Mucosal inflammation	General disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—
Fatigue	General disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Neutrophil count decreased	Investigations	—	—
Stomatitis	Gastrointestinal disorders	—	—
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Neutropenia, Febrile neutropenia, Thrombocytopenia, Vomiting, Dyspnoea, Anaemia, Pancytopenia, Pyrexia.

Data from ClinicalTrials.gov NCT02825420 adverse events section.

Sponsor's own description

Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A European, Observational, Prospective Trial of Trabectedin Plus Pegylated Liposomal Doxorubicin in Patients with Platinum-Sensitive Ovarian Cancer.
   Pignata S, Scambia G, Villanucci A, Naglieri E, et al · · 2021 · cited 17× · PMID 33289956 · DOI 10.1002/onco.13630
2. DNA Damage Response Alterations in Ovarian Cancer: From Molecular Mechanisms to Therapeutic Opportunities.
   Ovejero-Sánchez M, González-Sarmiento R, Herrero AB. · · 2023 · cited 16× · PMID 36672401 · DOI 10.3390/cancers15020448
3. Combinational use of trabectedin and pegylated liposomal doxorubicin for recurrent ovarian cancer: a meta-analysis of phase III randomized controlled trials.
   Li C, Qiao S, Kang M, Gao X, et al · · 2023 · cited 3× · PMID 38186978