Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
Conditions
Brief summary
M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients. The study objective is to assess the safety and the performance of the M-Trap device.
Interventions
DEVICEM-Trap
Device(s) will be surgically implanted in the peritoneal cavity. Up to three (3) M-Trap devices will be surgically implanted via laparotomy in the right and left paracolic (pelvic) gutters and behind segment 6 of the liver within the peritoneal cavity of the patient at the time of surgical resection. Patients will receive standard platinum-based chemotherapy. If the cancer is diagnosed to have recurred, M-Trap devices with captured tumor cells will be removed via minimally invasive surgery (laparoscopy).
Sponsors
MedPass International
MTrap, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center, non-blinded, single-arm study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is a female ≥18 years old. 2. Presents with a diagnosis of Stage IIIC ovarian cancer. 3. Presents with high-grade serous carcinoma. 4. Has one of the following: 1. Visible residual tumor ≤1 cm after primary tumor debulking surgery. 2. Three cycles of neoadjuvant chemotherapy and complete resection after interval tumor debulking surgery. 3. Three cycles of neoadjuvant chemotherapy and visible residual tumor ≤1 cm after interval tumor debulking surgery. 5. ECOG performance status of 0 or 1. 6. Is willing to comply with required follow-up study visits. 7. Is willing and able to provide written informed consent.
Exclusion criteria
1. Has a life expectancy of \<3 months. 2. Is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating. 3. Will be receiving intraperitoneal chemotherapy. 4. Has undergone prior treatment with abdominal and/or pelvic radiotherapy. 5. Has significant active concurrent medical illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Presence of central nervous system or cerebral metastases. 7. Recurrent ovarian cancer. 8. Complete resection with no residual tumor after primary tumor debulking surgery. 9. Suboptimal resection with \>1 cm residual tumor after primary or interval tumor debulking surgery. 10. Is simultaneously enrolled in another investigational study. 11. Has a history of cancer within 5 years other than in-situ uterine cervix cancer or non-melanoma skin cancer. 12. Has a known hypersensitivity to carboplatin or paclitaxel. 13. Is concurrently using other antineoplastic agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events | 6 months | The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites. |
| Performance: Number of Participants With Histological Evidence of Tumor Cell Capture | Time of device removal, an average of 13.3 months | Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting | 18 months | Procedure-related long-term adverse events and serious adverse events reported through 18 months |
| Safety: Number of Participants With Device-related Long-term Adverse Event Reporting | 18 months | Device-related long-term adverse events and serious adverse events reported through 18 months |
| Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | Time of recurrence, an average of 14.5 months | Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease Focalization Score by Recurrence Status | Time of recurrence, an average of 14.5 months | Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device |
| Number of Participants With Reasons for Device Removal | Time of device removal, an average of 13.3 months | Reason that device removal was planned, regardless of whether or not it was completed. |
| Number of Devices Implanted | Immediately post-procedure | Number of devices implanted at conclusion of debulking surgery. |
Countries
Spain
Participant flow
Recruitment details
Prospective, multi-center, non-blinded, single-arm study
Participants by arm
| Arm | Count |
|---|---|
| M-Trap M-Trap: Device(s) will be surgically implanted in the peritoneal cavity. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 2 |
Baseline characteristics
| Characteristic | M-Trap | — |
|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 9.5 | — |
| BMI | 25.8 kg/m^2 STANDARD_DEVIATION 3.7 | — |
| ECOG Performance Status Grade 0 | 16 Participants | — |
| ECOG Performance Status Grade 1 | 7 Participants | — |
| Ovarian Cancer Stage IIIC | 18 Participants | — |
| Ovarian Cancer Stage IVA | 1 Participants | — |
| Ovarian Cancer Stage IVB | 4 Participants | — |
| Post-debulking PCI All patients | 1.3 scores on a scale STANDARD_DEVIATION 1.5 | — |
| Post-debulking PCI Interval debulking | 0.6 scores on a scale STANDARD_DEVIATION 1.1 | — |
| Post-debulking PCI Primary debulking | 2.7 scores on a scale STANDARD_DEVIATION 1.1 | — |
| Pre-debulking PCI All patients | 17.8 scores on a scale STANDARD_DEVIATION 8.3 | — |
| Pre-debulking PCI Interval debulking | 13.7 scores on a scale STANDARD_DEVIATION 7.1 | — |
| Pre-debulking PCI Primary debulking | 25.5 scores on a scale STANDARD_DEVIATION 3.4 | — |
| Pregnancy Negative pregnancy test | 2 Participants | — |
| Pregnancy Post-menopause | 18 Participants | — |
| Pregnancy Prior hysterectomy | 3 Participants | — |
| Pre-operative hemoglobin | 11.3 g/dl STANDARD_DEVIATION 1.4 | — |
| Pre-operative serum albumin | 6.5 g/dl STANDARD_DEVIATION 8.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Spain | 23 Participants | — |
| Sex: Female, Male Female | 23 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
| Total number of extended procedures 1 extended procedure | 1 Participants | — |
| Total number of extended procedures 2 extended procedures | 8 Participants | — |
| Total number of extended procedures 3 or more extended procedures | 14 Participants | — |
| Type of debulking procedure Interval with 3 rounds of chemotherapy | 11 Participants | — |
| Type of debulking procedure Interval with 4 rounds of chemotherapy | 4 Participants | — |
| Type of debulking procedure Primary | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 23 |
| other Total, other adverse events | 23 / 23 |
| serious Total, serious adverse events | 11 / 23 |
Outcome results
Primary
Performance: Number of Participants With Histological Evidence of Tumor Cell Capture
Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal
Time frame: Time of device removal, an average of 13.3 months
Population: Assessment was completed in all patients who underwent successful device removal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-Trap | Performance: Number of Participants With Histological Evidence of Tumor Cell Capture | 2 Participants |
| Platinum Sensitive, Recurrent Patients | Performance: Number of Participants With Histological Evidence of Tumor Cell Capture | 6 Participants |
| Non-recurrent | Performance: Number of Participants With Histological Evidence of Tumor Cell Capture | 2 Participants |
| All Recurrent Patients | Performance: Number of Participants With Histological Evidence of Tumor Cell Capture | 8 Participants |
| All Patients | Performance: Number of Participants With Histological Evidence of Tumor Cell Capture | 10 Participants |
Primary
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites.
Time frame: 6 months
Population: All enrolled patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-Trap | Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events | 18 Participants |
Comparison: H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)p-value: 0.1309unilateral one sample test for binomial
Primary
Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites, adjusted based on the breakdown of the historical control population by number of extended procedures
Time frame: 30 days
Population: All enrolled patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-Trap | Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events | 20 Participants |
Comparison: H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)p-value: 0.0181unilateral one sample test for binomial
Secondary
Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status
Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization.
Time frame: Time of recurrence, an average of 14.5 months
Population: All patients with disease focalization scores reported
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-Trap | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II, III or IV | 2 Participants |
| M-Trap | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I | 0 Participants |
| M-Trap | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | No focalization | 2 Participants |
| M-Trap | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I or II | 0 Participants |
| M-Trap | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II or III | 0 Participants |
| Platinum Sensitive, Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II, III or IV | 7 Participants |
| Platinum Sensitive, Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II or III | 1 Participants |
| Platinum Sensitive, Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I or II | 0 Participants |
| Platinum Sensitive, Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | No focalization | 2 Participants |
| Platinum Sensitive, Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I | 0 Participants |
| Non-recurrent | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II or III | 0 Participants |
| Non-recurrent | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I | 0 Participants |
| Non-recurrent | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I or II | 0 Participants |
| Non-recurrent | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II, III or IV | 0 Participants |
| Non-recurrent | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | No focalization | 7 Participants |
| All Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | No focalization | 4 Participants |
| All Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I | 0 Participants |
| All Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II, III or IV | 9 Participants |
| All Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II or III | 1 Participants |
| All Recurrent Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I or II | 0 Participants |
| All Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II or III | 1 Participants |
| All Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I, II, III or IV | 9 Participants |
| All Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I | 0 Participants |
| All Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | No focalization | 11 Participants |
| All Patients | Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status | I or II | 0 Participants |
Secondary
Safety: Number of Participants With Device-related Long-term Adverse Event Reporting
Device-related long-term adverse events and serious adverse events reported through 18 months
Time frame: 18 months
Population: All enrolled patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-Trap | Safety: Number of Participants With Device-related Long-term Adverse Event Reporting | 1 Participants |
Secondary
Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting
Procedure-related long-term adverse events and serious adverse events reported through 18 months
Time frame: 18 months
Population: All enrolled patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-Trap | Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting | 21 Participants |
Other Pre-specified
Disease Focalization Score by Recurrence Status
Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device
Time frame: Time of recurrence, an average of 14.5 months
Population: All patients with disease focalization scores reported
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-Trap | Disease Focalization Score by Recurrence Status | IV (~25% focalized) | 2 Participants |
| M-Trap | Disease Focalization Score by Recurrence Status | I (100% focalized) | 0 Participants |
| M-Trap | Disease Focalization Score by Recurrence Status | V (no focalization) | 2 Participants |
| M-Trap | Disease Focalization Score by Recurrence Status | II (~75% focalized | 0 Participants |
| M-Trap | Disease Focalization Score by Recurrence Status | III (~50% focalized) | 0 Participants |
| Platinum Sensitive, Recurrent Patients | Disease Focalization Score by Recurrence Status | IV (~25% focalized) | 6 Participants |
| Platinum Sensitive, Recurrent Patients | Disease Focalization Score by Recurrence Status | III (~50% focalized) | 1 Participants |
| Platinum Sensitive, Recurrent Patients | Disease Focalization Score by Recurrence Status | II (~75% focalized | 0 Participants |
| Platinum Sensitive, Recurrent Patients | Disease Focalization Score by Recurrence Status | V (no focalization) | 3 Participants |
| Platinum Sensitive, Recurrent Patients | Disease Focalization Score by Recurrence Status | I (100% focalized) | 0 Participants |
| Non-recurrent | Disease Focalization Score by Recurrence Status | III (~50% focalized) | 0 Participants |
| Non-recurrent | Disease Focalization Score by Recurrence Status | I (100% focalized) | 0 Participants |
| Non-recurrent | Disease Focalization Score by Recurrence Status | II (~75% focalized | 0 Participants |
| Non-recurrent | Disease Focalization Score by Recurrence Status | IV (~25% focalized) | 0 Participants |
| Non-recurrent | Disease Focalization Score by Recurrence Status | V (no focalization) | 7 Participants |
| All Recurrent Patients | Disease Focalization Score by Recurrence Status | V (no focalization) | 5 Participants |
| All Recurrent Patients | Disease Focalization Score by Recurrence Status | I (100% focalized) | 0 Participants |
| All Recurrent Patients | Disease Focalization Score by Recurrence Status | IV (~25% focalized) | 8 Participants |
| All Recurrent Patients | Disease Focalization Score by Recurrence Status | III (~50% focalized) | 1 Participants |
| All Recurrent Patients | Disease Focalization Score by Recurrence Status | II (~75% focalized | 0 Participants |
| All Patients | Disease Focalization Score by Recurrence Status | III (~50% focalized) | 1 Participants |
| All Patients | Disease Focalization Score by Recurrence Status | IV (~25% focalized) | 8 Participants |
| All Patients | Disease Focalization Score by Recurrence Status | I (100% focalized) | 0 Participants |
| All Patients | Disease Focalization Score by Recurrence Status | V (no focalization) | 12 Participants |
| All Patients | Disease Focalization Score by Recurrence Status | II (~75% focalized | 0 Participants |
Other Pre-specified
Number of Devices Implanted
Number of devices implanted at conclusion of debulking surgery.
Time frame: Immediately post-procedure
Population: All patients
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-Trap | Number of Devices Implanted | 2 devices | 1 Participants |
| M-Trap | Number of Devices Implanted | 3 devices | 22 Participants |
Other Pre-specified
Number of Participants With Reasons for Device Removal
Reason that device removal was planned, regardless of whether or not it was completed.
Time frame: Time of device removal, an average of 13.3 months
Population: All enrolled patients
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-Trap | Number of Participants With Reasons for Device Removal | Device-related adverse event necessitating removal | 1 Participants |
| M-Trap | Number of Participants With Reasons for Device Removal | Disease progression | 15 Participants |
| M-Trap | Number of Participants With Reasons for Device Removal | Final 18-month post-implantation time point | 5 Participants |
| M-Trap | Number of Participants With Reasons for Device Removal | Major adverse event not related with the device | 1 Participants |
| M-Trap | Number of Participants With Reasons for Device Removal | Death prior to removal | 1 Participants |
Post Hoc
Tumor Cell Infiltration
Estimate of tumor cell infiltration into the device based on histopathological analysis of devices from recurrent patients who underwent successful device removal. Percentage of device was determined by analysis of one slide from one tissue block (0.3 cm thick), by considering the amount of tumor cells in comparison to the total number of cells present in the slide when analyzed using image analysis with a digital slide scanner \[Membrane Quant Module, Panoramic 250 FLASH II 2.0 (3D HISTEC)\].
Time frame: Time of recurrence, an average of 14.5 months
Population: Recurrent patients who underwent successful device removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M-Trap | Tumor Cell Infiltration | 1.7 percentage of device | Standard Deviation 2.5 |