Fallopian Tube Cancer Clinical Trial
Official title:
A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)
Verified date | May 2024 |
Source | Genelux Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.
Status | Recruiting |
Enrollment | 186 |
Est. completion date | October 2026 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer. - High-grade serous [including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 & 3 allowed], endometrioid, or clear-cell ovarian cancer. - Performance status ECOG of 0 or 1. - Life expectancy of at least 6 months. - Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit. - Time from Last Platinum of less than or equal to 24 months since the last dose of platinum in the most recent platinum-based line of therapy (excluding using platinum as a radiosensitizer) until consent into this trial. - Platinum-resistant or -refractory disease based on platinum-free interval (PFI) from the last dose of the most recent. platinum-based line of therapy (must have received a minimum of 2 doses of platinum in that line) to subsequent disease progression based on radiological assessment. Platinum-refractory: PFI of < 1 month (including disease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6 months. - Received prior bevacizumab (or biosimilar) treatment. - No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar). - Have disease progression after last prior line of therapy based on radiological assessment prior to randomization. - At least 1 measurable target lesion per RECIST 1.1 based on abdominal/pelvis imaging scan at screening. - Evidence by CT and/or PET scans or physical exam of abdominal/pelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis). - Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count. Exclusion Criteria: - Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors). - Bowel obstruction within last 3 months prior to screening. - Active urinary tract infection, pneumonia, other systemic infections. - Active gastrointestinal bleeding. - Known current central nervous system (CNS) metastasis. - Inflammatory diseases of the bowel. - History of HIV infection. - Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study. - History of thromboembolic event within the prior 3 months. - Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen. - Clinically significant cardiac disease at screening (New York Heart Association Class III/IV). - Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months. - Oxygen saturation <90%. - Received prior virus-based gene therapy or therapy with cytolytic virus of any type. - Receiving concurrent antiviral agent. - Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal/squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I/II local malignancies. - Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment. - Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm. - Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent. - Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis > once every 14 days. - Known hypersensitivity to gentamicin. |
Country | Name | City | State |
---|---|---|---|
United States | Hollings Cancer Center | Charleston | South Carolina |
United States | Levine Cancer Institute | Charlotte | North Carolina |
United States | Chattanooga's Program in Women's Oncology | Chattanooga | Tennessee |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | City of Hope | Duarte | California |
United States | Indiana University Simon Comprehensive Cancer Center | Indianapolis | Indiana |
United States | Kettering Health | Kettering | Ohio |
United States | UC San Diego Health - Moores Cancer Center | La Jolla | California |
United States | The University of South Alabama, Mitchell Cancer Institute | Mobile | Alabama |
United States | Hoag Gynecologic Oncology | Newport Beach | California |
United States | Oklahoma University Health Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | UCI Health Chao Family Comprehensive Cancer Center | Orange | California |
United States | AdventHealth Cancer Institute | Orlando | Florida |
United States | AHN West Penn Hospital | Pittsburgh | Pennsylvania |
United States | Center of Hope | Reno | Nevada |
United States | Mercy Hospital St. Louis | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Holy Cross Hospital | Silver Spring | Maryland |
United States | Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington |
United States | Tampa General Hospital/University of South Florida | Tampa | Florida |
United States | Women's Cancer Associates with Women's Care Florida | Tampa | Florida |
United States | University of Arizona Cancer Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Genelux Corporation | GOG Foundation |
United States,
Holloway RW, Mendivil AA, Kendrick JE, Abaid LN, Brown JV, Fitzsimmons CK, Kennard JA, King M, LeBlanc J, Lopez K, Manyam M, McKenzie ND, Mori KM, Stephens AJ, Sarfraz A. 2020 International Gynecologic Cancer Society, Oral Plenary Session presentation of
Holloway RW, Mendivil AA, Kendrick JE, Abaid LN, Brown JV, LeBlanc J, McKenzie ND, Mori KM, Ahmad S. Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory O — View Citation
Manyam M, Stephens AJ, Kennard JA, LeBlanc J, Ahmad S, Kendrick JE, Holloway RW. A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer. Gynecol Oncol. 2021 Dec;163(3):481-489. doi: 10.1016/j.y — View Citation
Mori KM, Giuliano PD, Lopez KL, King MM, Bohart R, Goldstein BH. Pronounced clinical response following the oncolytic vaccinia virus GL-ONC1 and chemotherapy in a heavily pretreated ovarian cancer patient. Anticancer Drugs. 2019 Nov;30(10):1064-1066. doi: 10.1097/CAD.0000000000000836. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) by RECIST 1.1 in the Intention-to-Treat (ITT) population (all randomized participants regardless of whether they received any dose of treatment) | To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause. | From date of randomization up to 12 months | |
Secondary | Incidence of Treatment-emergent Adverse Events in the ITT population | Determine safety and tolerability of administering multiple doses of Olvi-Vec via intraperitoneal catheter in combination with platinum-doublet and bevacizumab (or biosimilar) as assessed by CTCAE v. 5.0 following initiation of study treatment until end of study participation. | From date of first study treatment until death or study completion; assessed up to 36 months | |
Secondary | Duration of Response (DOR) by RECIST 1.1 in the ITT population | Time from date of first response until the first date of progressive disease based on radiological assessment. | From date of randomization up to 12 months | |
Secondary | PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm) | Time from randomization to first documented disease progression based on radiological assessment or death from any cause. | From date of randomization up to 12 months | |
Secondary | PFS by iRECIST in the ITT population | Time from randomization to first documented disease progression with confirmatory imaging scan performed 4-8 weeks after unconfirmed disease progression or death from any cause. | From date of randomization up to 12 months | |
Secondary | Overall Response Rate (ORR) by RECIST 1.1 in the ITT population | Ratio of the sum of CR & PR divided by the number of ITT participants from start of treatment to confirmation of response. | From date of randomization up to 12 months | |
Secondary | Overall Survival in the ITT population | Time from randomization until date of death from any cause. | From date of randomization until death or study completion; assessed up to 36 months |
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