Neoplasms

All Conditions

Rare Diseases

Chordoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Oculocerebral Syndrome With Hypopigmentation

All Drugs and Chemicals

Other Dietary Supplements

Vaccines

Brewer's Yeast

Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee.

Placebo

GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product.

GI-6301 Vaccine (Yeast- Brachyury)

Radiotherapy

wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9

wGT3X-BT Actigraph

This is a phase 2 clinical trial to determine whether the yeast-brachyury vaccine GI-6301 improves the effectiveness of radiation for patients with localized chordoma. Chordoma patients with inoperable or residual tumor who do not have metastases and are planning to be treated with definitive (\>70Gy) radiation were enrolled. Patients were randomized to receive radiation plus the vaccine or radiation plus a blinded placebo. The study compared the outcomes of patients treated with radiation with and without the vaccine to determine whether the vaccine can increase the chances of shrinking the tumor and/or preventing further tumor growth.

Chordoma is a rare disease, affecting about 3,000 people in the United States. There have been indications of clinical benefit in patients with chordoma enrolled on the phase I trial of GI-6301.

PRIMARY OBJECTIVE: To determine if there is a difference in overall response rate (ORR) defined as complete response (CR) or partial response (PR) by RECIST 1.1 after up to 24 months among patients with Chordoma who are treated with radiation plus placebo vs. radiation plus vaccine.

QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma

A Randomized, Double-Blind, Phase 2 Trial of GI-6301 (Yeast-Brachyury Vaccine) Versus Placebo in Combination With Standard of Care Definitive Radiotherapy in Locally Advanced, Unresectable, Chordoma

Difference in overall response rate among patients with Chordoma who are treated with radiation plus placebo vs. radiation plus vaccine.

Overall response rate (ORR) defined as complete response (CR) or partial response (PR) by RECIST 1.1 in the irradiated tumor site after up to 24 months among patients with Chordoma who are treated with radiation plus vaccine vs. radiation plus placebo

Complete response (CR; disappearance of all target lesions and no new lesions) or partial response (PR; \>=30% decrease in the sum of the greatest diameter).

National Cancer Institute (NCI)

NantCell, Inc.

Radiation + GI-6301 Vaccine + Actigraph

GI-6301 Vaccine (Yeast- Brachyury): GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product.

Radiotherapy: Standard of care

wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9

GI-6301 Vaccine

Radiation + GI-6301 Placebo + Actigraph

GI-6301 Placebo: GI-6301 Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of GI-6301 placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee.

Radiotherapy: Standard of care

wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9

Vaccine

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Subjects with Locally Advanced, Unresectable, Chordoma

Sandeep Bobby Reddy, Chief Medical Officer

Overall Response Rate

Overall Study

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Infections

Recurrence

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Virus Diseases

Adenocarcinoma, Clear Cell

Vaccinia

Adenomyoepithelioma

Fallopian Tube Neoplasms

Adenocarcinoma

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

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Epithelial-myoepithelial Carcinoma

Antineoplastic Agents

Anti-Infective Agents

Gemcitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Bevacizumab

Carboplatin

Doxorubicin

Liposomal doxorubicin

Cisplatin

Immunomodulating Agents

Taxane

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

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

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Breast Neoplasms

Heart Arrest

Breast Diseases

Skin Diseases

Vinblastine

Part I: Patients will receive up to 3 doses of INT230-6 injected weekly prior to breast surgery

Part II: Patients will receive up to 2 intratumoral doses of INT230-6 (over a 15-day period) prior to breast surgery

Part I: No intervention while awaiting surgery

Part II: Placebo saline injection

INT230-6 is a formulation of two well known chemotherapeutic agents, cisplatin (0.5mg/mL) and vinblastine sulfate (0.1mg/mL), combined with 2-hydroxybenzoylaminooctanoate (also known as SHAO-FA or SHAO as a sodium salt at 10mg/mL).

INT230-6

Saline injection

Angel Arnaout, MD

Arif Awan, MD

This is a phase II, randomized, multi-center, parallel design, window of opportunity trial evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer. In a 2:1 randomization, patients on the treatment arm will receive intratumoral INT230-6 injections prior to breast surgery.

The study comprises 2 consecutive parts. The first part will be to test safety and feasibility of the dosing procedures. Results from Part I of the study will standardise the optimal dose and frequency of INT230-6 for participants in Part II.

Part I: Open-label 2:1 randomized study of up to 30 patients. Treatment arm patients will be given up to 3 doses of INT230-6 injected weekly prior to breast surgery, at a dose based on longest diameter. The control arm patients receive no treatment.

Part II: Double-blind, 2:1 randomized study of up to an additional 60 patients. The placebo arm includes a saline injection of similar dose and frequency as the treatment arm (up to 2 doses of INT230-6/saline injected weekly prior to breast surgery).

INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer

A Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological Effects of Intratumoral INT230-6 in Early Stage Breast Cancer: The INVINCIBLE Trial

Tumor's viable plus necrotic tissue, at the post-treatment specimen.

Assessed by the local pathologist at the time of definitive surgery in subjects with breast cancer

Comparison of pre (diagnostic biopsy) and post treatment (surgical resection) samples

overall safety of INT230-6 injected prior to surgery

Intensity Therapeutics, Inc.

Ontario Institute for Cancer Research

Ottawa Hospital Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma	NCT02383498	Chordoma	Placebo GI-6301 Vaccine... Radiotherapy wGT3X-BT Actigr...	18 Years - 100 Years	NantCell, 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
QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma	NCT02383498	Chordoma	Placebo GI-6301 Vaccine... Radiotherapy wGT3X-BT Actigr...	18 Years - 100 Years	NantCell, Inc.
INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer	NCT04781725	Breast Cancer	INT230-6 Saline injectio...	-	Ottawa Hospital Research Institute

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