Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT C
Conditions
Interventions
Sponsors
Mural Oncology, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: English 1. Patient is female and =18 years of age. 2. Patient or patient's legal representative (as applicable per regional requirements) has provided written informed consent. 3. Patient is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study. 4. Patient has histologically confirmed diagnosis of EOC, fallopian tube cancer, or primary peritoneal cancer and histology subtype, high-grade serous, endometrioid of any grade, clear cell 5. Patient has platinum-resistant/refractory disease: disease: resistant is defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (ie, initial platinum therapy); and refractory is defined as disease progression or lack of response followed by disease progression while receiving the most recent platinum-based therapy (beyond initial therapy) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically or by GCIG-defined CA-125 criteria on or after their most recent line of anticancer therapy beyond first-line setting. a. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression or the date progression was assessed by GCIG-defined CA-125 criteria, whichever comes first. b. Note: Patients who have primary platinum-refractory or platinumresistant disease (disease progression <3 months after completion of first-line platinum based therapy) are excluded. 6. Patient must have received at least 1 prior line of platinum-based therapy (as noted below), and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant disease (4 additional lines after the patient developed platinum-resistant/refractory disease). Patient must have received at least 1 line of therapy containing bevacizumab. The following guidelines apply: a. Patients who are primary platinum-resistant (developed resistance after initial platinum-based therapy) must have received at least 4 cycles of platinum, must have had a response (complete response [CR] or partial response [PR]) and then progressed =3 to =6 months after the date of the last dose of platinum b. Prior PARP inhibitor is allowed if included within these limits of prior therapy. Prior PARP inhibitor is required for patients with a breast cancer gene (BRCA) mutation. c. Adjuvant ± neoadjuvant is considered 1 line of therapy. d. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (i.e., not counted independently). e. Therapy that changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently). f. Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance therapy. 7. Patient has at least one measurable lesion that qualifies as a target lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are not considered measurable unless there has been demonstrated progression in the lesion. 8. Patient is willing to provide a tumor tissue sample either collected from a prior biopsy or cytoreductive/debulking surgery occurring at any time since diagnosis or from a fresh
Exclusion criteria
Exclusion criteria: 1. Patient has primary platinum-refractory disease or primary platinum resistance: primary platinum-refractory disease is defined as disease progression during initial platinum based therapy; and primary platinum resistance is defined as disease progression 10 mg of prednisone daily, or equivalent)within 14 days prior to the first dose of study drug(s); however, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted. Note: patients requiring the use of a steroid during the Screening Period at a dose level of <10 mg of prednisone (or equivalent) per day are not excluded as long as the event requiring the use of the steroid has recovered to acceptable grade. 8. Patient has taken nonsteroid systemic immunomodulatory agents (eg,etanercept, adalimumab, etc.) within 28 days prior to the first dose of study drug(s), or anticipates any use of these therapies during the study period. 9. Patient has undergone any major surgical procedure within 3 weeks prior to Screening. Patients who have not recovered from any previous surgery that occurred more than 3 weeks prior to Screening are also excluded. 10. Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant. 11. Patient has received a live or live-attenuated vaccine(s) within 30 days prior to the first dose of study drug(s). Note: Coronavirus Disease 2019 (COVID-19) vaccine is allowed; see guidance on COVID-19 vaccines in Section 7.3.2). 12. Patient has had any active infection and/or a fever =38.5°C (= 101°F) within 3 days prior to the first dose of study drug(s) requiring systemic therapy. Antibiotics given for periprocedural prophylaxis or given presumptively for a limited time (eg, until infection was ruled out), as well as topical or intraocular antibiotics, shall not be exclusionary. 13. Patient has active autoimmune disease(s) requiring systemic treatment within the past 2 years or a documented history of clinically severe autoimmune disease that has required chronic or frequent systemic steroids. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed. 14. Patient has underlying chronic lung disease, chronic obstructive pulmonary disease, metastatic lung disease, pleural effusions, or other lung disorders (eg, pulmonary embolism) with a baseline room air oxygen saturation of <92% at screening and/or dyspnea (=Grade 3)which requires oxygen therapy. 15. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. 16. Patient has any other concurrent uncontrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall survival (OS) of nemvaleukin in combination with pembrolizumab as compared with chemotherapy in patients with platinum resistant ovarian cancer ;Secondary Objective: • To evaluate the antitumor activity of nemvaleukin in combination with pembrolizumab as compared with chemotherapy • To evaluate the safety of nemvaleukin in combination with pembrolizumab as compared with chemotherapy;Primary end point(s): OS ;Timepoint(s) of evaluation of this end point: OS is defined as the time from randomization to death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression-free survival (PFS) as assessed by Investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 • Objective response rate (ORR) as assessed by Investigator, based on RECIST v1.1; • Overall Survival (OS) • Disease control rate (DCR), duration of response (DOR), and time to response (TTR) as assessed by Investigator, based on RECIST v1.1 • Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG) • Safety as assessed by treatment-emergent AEs (TEAEs), clinical laboratory parameters, vital signs, and electrocardiograms (ECGs);Timepoint(s) of evaluation of this end point: - PFS is defined as the time from randomization to the first documentation of objective tumor progression (by RECIST v1.1) or death due to any cause. - ORR is defined as the proportion of patients in the analysis population who have a CR or PR. - DCR is defined as the proportion of patients with objective evidence of CR, PR, or SD. For SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. - DOR is defined as the time from the first documentation of CR or PR to the first documentation of objective tumor progression or death due to any cause. -TTR is defined as the time from randomization to the first documentation of CR or PR. | — |
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Korea, Republic of, Lithuania, Netherlands, Norway, Poland, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactElizabeth Keane
Mural Oncology, Inc.
Outcome results
None listed