Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Vaccines

Immunologic Factors

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).

Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).

Vigil™ Vaccine

Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Minal Barve, MD

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.

Salvage Ovarian FANG™ Vaccine + Bevacizumab

Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) Integrated With Bevacizumab for Patients With Recurrent/Refractory Ovarian Cancer Participating in Study CL-PTL 105

Time to progression (TTP) following bevacizumab integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.

Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.

Survival status of patients after treatment was determined by following these patients up to 24 months.

To determine if subjects will have a positive (defined as \>10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.

Gradalis, Inc.

Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).

Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).

Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Age, Customized

Sex: Female, Male

White/Caucasian

Black/African American

Asian

Hispanic

Other

Race/Ethnicity, Customized

Director of Clinical Trials

5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.

Time to Progression

Response Rate

Alive Subjects After 24 months

Dead Subjects After 24 months

5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 24 months, only 1 of the 5 subjects was alive. Statistical analysis was not done. This study was terminated.

Number of Alive Subjects

ELISPOT-Positive After 12 months

ELISPOT-Negative After 12 months

5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 12 months, all 5 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.

Enzyme-Linked ImmunoSorbent Spot (ELISPOT)

Overall Study

Infections

Virus Diseases

Adenocarcinoma, Clear Cell

Vaccinia

Adenomyoepithelioma

Fallopian Tube Neoplasms

Adenocarcinoma

Fallopian Tube Diseases

Fallopian Tube Cancer

Epithelial-myoepithelial Carcinoma

Anti-Infective Agents

Gemcitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Carboplatin

Doxorubicin

Liposomal doxorubicin

Cisplatin

Immunomodulating Agents

Taxane

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Olvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0

Platinum-doublet \& bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5

Physician's Choice of chemotherapy \& bevacizumab (or biosimilar) administered beginning in Week 0. Physician's Choice of chemotherapy includes either a single agent non-platinum chemotherapy, or as platinum chemotherapy is allowed as an option, a platinum-doublet (i.e., platinum agent combined with a non-platinum agent).

Olvi-Vec is an engineered oncolytic vaccinia virus

olvimulogene nanivacirepvec

Platinum chemotherapy: carboplatin (preferred) or cisplatin

Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin

Bevacizumab (or biosimilar)

Stefanie White

Jennifer M Scalici, MD

Claudia Al Khairi

Setsuko K. Chambers, MD

Edward Wang, MD, PhD

Alexandrea Cronin

Michael McHale, MD

Ramez Eskander, MD

Esmeralda Martinez

Alberto Mendivil, MD

Krishnansu S. Tewari, MD

Karla Hernandez-Cruz

Robert W Holloway, MD

Monica Rengifo Pardo, MD

Matthew L. Anderson, MD, PhD

Megan Indermaur, MD

Rebekah Little, CRC

Cheri West, RN

Jessica E. Parker, MD

Lyudmila Igorevna Kalnitskaya, MBA, MS

James F Barter, MD

Robert Morris, MD

Linda Odibo

Premal Thaker, MD

Crystal Tindall, BSN, RN

Jessica Black

Dan-Arin Silasi, MD

Peter Lim, MD

Leah Wilson

Erin K Crane, MD

Jackie Ludwig

Peter Rose, MD

Daniel Geyer

Tammy Bonham

Thomas J. Reid, MD

Debra Richardson, MD

Ashma Acharya

Sarah Crafton, MD

Crystal Knox

Whitney S Graybill, MD

Stephen DePasquale, MD

Kim Donelson, LPN CCRP

Jodie Mactagone, CRC

Melanie Bergman, MD

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.

Olvi-Vec (olvimulogene nanivacirepvec, aka GL-ONC1, laboratory name: GLV-1h68) is an oncolytic vaccinia virus-based immunotherapy. This study is to test the hypothesis that the combination of Olvi-Vec followed by further chemotherapy is particularly effective against established tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy. Participant population includes histologically confirmed non-resectable platinum-resistant/refractory ovarian cancer (PRROC). Determination of progression-free survival, safety and overall survival are key objectives. Participants randomized into the Experimental Arm will receive a single-cycle (2 infusions on two consecutive days) of Olvi-Vec through an intraperitoneal catheter. The catheter is then removed, and patients receive systemically administered platinum-doublet chemotherapy and bevacizumab. The control arm receives the Physician's Choice of chemotherapy and bevacizumab at the same dose and schedule. Biological samples will be obtained from some Experimental Arm participants for virus-shedding testing. Assessment of response to treatment in both arms will be by RECIST 1.1 and iRECIST as assessed by Blinded Independent Central Review. Maintenance/continued treatment with non-platinum chemotherapy and bevacizumab is dependent on a participant being clinically stable until confirmed progressive disease by iRECIST or can no longer tolerate therapy.

Dr. Robert W. Holloway (AdventHealth Cancer Institute, Orlando, FL) will serve as the National Principal Investigator for this Phase 3 study in PRROC.

Randomization (2:1) is either into the Experimental Arm which is Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab or into the Active Comparator Arm which is Physician's Choice of chemotherapy and bevacizumab.

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

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)

To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.

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.

Time from date of first response until the first date of progressive disease based on radiological assessment.

Time from randomization to first documented disease progression based on radiological assessment or death from any cause.

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.

Ratio of the sum of CR \& PR divided by the number of ITT participants from start of treatment to confirmation of response.

Time from randomization until date of death from any cause.

GOG Foundation

Genelux Corporation

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Placebo

Isabelle RAY COQUARD, MD, PhD

Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.

Patients with advanced FIGO stage IIIB - IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer treated with standard first-line treatment, combining platinum-taxane chemotherapy and bevacizumab concurrent with chemotherapy and in maintenance.

Platine, Avastin and OLAparib in 1st Line

Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment

Overall survival is defined as the time from the date of randomization until death due to any cause.

Time to earliest progression by RECIST v. 1.1 or CA-125 or death is defined as the time from randomization to the earliest date of RECIST or CA-125 progression or death by any cause.

Time from randomization to second progression is defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the primary variable PFS, or date of death.

Time to start of first subsequent therapy or death (TFST) will be assessed. TFST is defined as the time from the date of randomization to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death.

Time to start of second subsequent therapy or death (TSST) will be assessed. TSST is defined as the time from the date of randomization to the earliest of the date of second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.

Arbeitsgemeinschaft Gynaekologishe Onkologie Germany

Arbeitsgemeinschaft Gynaekologische Onkologie Austria

Grupo Español de Investigación en Cáncer de Ovario

Belgian Gynaecological Oncology Group

Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies

Mario Negri Gynecologic Oncology group (MaNGO)

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Gynecologic Oncology Trial & Investigation Consortium

Arcagy Research

Central Nervous System Depressants

Pharmaceutical Solutions

Other Dietary Supplements

Benzocaine

Plasma-lyte 148

Dimethyl Sulfoxide

Tannic Acid

Vigil immunotherapy will be administered at a concentration of 1.0 x 10e7 cells/dose given via intradermal injection every 4 weeks for a minimum of 4 and a maximum of 6 administrations as determined by the number of doses manufactured and as long as the subject is clinically stable and recurrence free.

Placebo will be administered via intradermal injection every 4 weeks for a minimum of 4 and a maximum of 6 administrations as determined by the number of doses manufactured and as long as the subject is clinically stable and recurrence free.

The bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine, Vigil is made up of irradiated autologous tumor cells which have been electroporated ex vivo with the Vigil plasmid designed to suppress expression of both the TGFβ1 and TGFβ2 proteins while simultaneously expressing rhGMCSF protein.

Vigil

To maintain placebo effect and eliminate bias due to volumetric differences, the number of Vigil doses manufactured from harvested tissue (except if below 4) will be used to guide manufacture of the same number of doses of placebo for each subject. Placebo will consist of "freeze" media \[10% DMSO (dimethyl sulfoxide; Cryoserv USP; Mylan Institutional USP), 1% Human Serum Albumin (ABO Pharmaceuticals) in Plasma-Lyte A, pH 7.4 (Baxter)\]. Depending upon randomization assignment, placebo or Vigil will be delivered in identical vials and drawn up in 'covered' syringes for intradermal injection.

John Nemunaitis, MD

The goal of this clinical trial is to compare participants with ovarian, fallopian tube or primary peritoneal cancer when treated with investigational product (Vigil) compared to placebo. The main question it aims to answer is "Will participants who receive treatment with Vigil have a longer time to disease recurrence versus the participants that were not given Vigil?"

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study of maintenance Vigil Ovarian (gemogenovatucel-T) engineered autologous tumor cells (EATC) in women with Stage IIIb, IIIc or IV high-grade papillary serous/ clear cell / endometrioid ovarian, fallopian tube or primary peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking or initial diagnostic / evaluative laparoscopy (tissue for immunotherapy manufacture must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of placebo doses will be manufactured. Subjects eligible for randomization will have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy. Clinical complete response (cCR) is defined as no evidence of maligancy on chest x-ray and CT scan or MRI of the abdomen and pelvis, CA-125 antigen level ≤ units/mL, and no findings on physical examination or symptoms suggestive of active cancer.

Investigational treatment must start no less than 3 weeks and no more than 8 weeks following completion of chemotherapy.

Approximately 86 subjects will be randomized 1:1 to to Group A (Vigil 1.0 X 10e7 cells/injection) or Group B (placebo). Randomization will be stratified by (i) extent of surgical cytoreduction (complete/microscopic versus macroscopic residual disease) and (ii) neoadjuvant versus adjuvant chemotherapy. Participants will receive Vigil or placebo by intradermal injection once a month for at least 4 and up to a maximum of 6 doses determined by the number of doses of Vigil manufactured for that subject.

Participants will be managed in an outpatient setting. Image assessment with chest x-ray and CT scan or MRI of the abdomen and pelvis will be completed every 3 months in Years 1-3, then every 6 months in Years 4 and 5 and yearly through Year 10. At the time the participant recurs, the participant will enter long term follow-up for survival status and post treatment therapies received.

A Trial of Vigil for Participants With Ovarian Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Salvage Ovarian FANG™ Vaccine + Bevacizumab	NCT01551745	Stage III Ovari... Stage IV Ovaria...	Vigil™ Vaccine Bevacizumab	18 Years -	Gradalis, Inc.
Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)	NCT05281471	Platinum-resist... Platinum-refrac... Fallopian Tube ... Primary Periton... High-grade Sero... Endometrioid Ov... Ovarian Clear C...	olvimulogene na... Platinum chemot... Non-platinum ch... Bevacizumab (or...	18 Years -	Genelux Corporation
Platine, Avastin and OLAparib in 1st Line	NCT02477644	Ovarian Cancer	Olaparib Placebo	18 Years -	Arcagy Research
Platine, Avastin and OLAparib in 1st Line	NCT02477644	Ovarian Cancer	Olaparib Placebo	18 Years -	Arcagy Research
A Trial of Vigil for Participants With Ovarian Cancer	NCT02346747	Ovarian Cancer Ovarian Neoplas...	Vigil Placebo	18 Years -	Gradalis, Inc.

Spots Global Cancer Trial Database for endometrioid ovarian cancer