Approval Probability
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IMNN-001 · 3 trials · 4 indications
To determine if the addition of IMNN-001 reduces the rate of histologically documented MRD as determined by SLL in the experimental group (chemotherapy + BEV + IMNN-001) as compared to the control group (chemotherapy + BEV).
The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus IMNN-001 versus standard NACT.
Dose-limiting toxicity
| Arm | Type | Description |
|---|---|---|
| Chemotherapy + BEV + IMNN-001 (Experimental) | EXPERIMENTAL | Chemotherapy (neoadjuvant and adjuvant): Paclitaxel 175 mg/m2 IV followed by carboplatin AUC 5-6 IV starting on C1D1. During the neoadjuvant period, there will be from 4 to 6 cycles repeated every 21 days. BEV 15 mg/kg IV administration will be included with each cycle except during the cycles around time of surgery. During maintenance, BEV will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV. IMNN-001 80 mg/m2 IP will be administered weekly beginning C1D15 and continue weekly through the last cycle of adjuvant therapy. At the conclusion of chemotherapy, GEN-1 will be administered every 21 days with BEV in subjects who are BRCA-/HRP until disease progression or unacceptable toxicity for up to an additional 18 cycles. |
| Chemotherapy + BEV (Control) | OTHER | Chemotherapy (neoadjuvant and adjuvant): Paclitaxel 175 mg/m2 IV followed by carboplatin AUC 5-6 IV starting on C1D1. During the neoadjuvant period, there will be from 4 to 6 cycles (at the Investigator's discretion, having an additional C4+1 and C4+2) repeated every 21 days. BEV 15 mg/kg IV administration will be included with each cycle EXCEPT the following cycles: \[1\] Cycle 1, \[2\] the last cycle of neoadjuvant therapy immediately preceding ICS, and \[3\] the first cycle of adjuvant chemotherapy (i.e., first cycle after ICS). During the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV. |
| NACT + IMNN-001 | EXPERIMENTAL | The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. IMNN-001 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments. |
| NACT Alone | ACTIVE_COMPARATOR | The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. |
| Single Arm | EXPERIMENTAL | Carboplatin + Paclitaxel + IMNN-001 |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Paclitaxel 175 mg/m2 IV |
| Carboplatin | DRUG | Carboplatin AUC 5-6 IV |
| Bevacizumab | DRUG | BEV 15 mg/kg IV administration will be included with each cycle EXCEPT the following cycles: \[1\] Cycle 1, \[2\] the last cycle of neoadjuvant therapy immediately preceding ICS, and \[3\] the first cycle of adjuvant chemotherapy (i.e., first cycle after ICS). During the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV. |
| IMNN-001 | DRUG | IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer |
Inclusion Criteria: 1. Subjects with ovarian, fallopian tube, or primary peritoneal carcinoma with high grade serous adenocarcinoma histology are eligible. Poorly differentiated carcinomas consistent with high grade serous histology are eligible. Pathologic diagnosis may be via frozen section or pe...