Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Recurrence

Carcinoma

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Fallopian Tube Neoplasms

Disease Attributes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Niraparib

Immunoglobulins

Oregovomab

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

* Niraparib (300/200 mg) will be administered orally once daily.
* Oregovomab (2 mg) will be administered via IV infusion on Day 1 of Week 1, Week 4, Week 7, Week 12, and Week 20.

2 mg, added to 50 mL of Sodium Chloride infused over 20 ± 5 minutes.

300mg administered orally once daily starting at the first day of treatment (Day 1 Week 1) to the end of Week 12. Subjects whose baseline weight is \<77 kg or platelet count is \<150,000 μL, the daily dosing will be 200mg.

Sunil Gupta, MD, FRCPC

Study to evaluate the safety and activity of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer.

Phase 2 single arm open label study to evaluate the combination of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer. Approximately 15 subjects will be screened to enroll approximately 10 evaluable subjects.

The study will include:

* Screening period up to 28 days prior to start of study treatment.
* Treatment period up to 24 weeks.
* Post-treatment follow-up period:
* Safety Follow-up: all subjects will be followed at least 30 days after end of treatment for safety.
* Long Term Follow-up: all subjects will be followed for survival approximately every 3 months for 1 year, until death, withdrawal of consent, lost to follow-up, or sponsor decision to close the study; or whichever comes first.

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

Phase 2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Niraparib as a Combinatorial Immune Priming Strategy in Subjects With Platinum Sensitive Recurrent Ovarian Cancer

Defined as date of first dose of study treatment to the date of event defined as the first documented progression as per RECIST v1.1

Defined as the portion of subjects who survive for 24 months after first dose.

Overall Response Rate (ORR) to alternate next-line therapy-initiated post Week 12 measured at Week 24 relative to their Week 12 assessment ((new baseline).

To evaluate anti-tumor activity of oregovomab added to niraparib by Disease Control Rate, defined as the portion of subjects with complete response (CR), partial response (PR) and stable disease (SD) at week 12. The DCR will be determined as defined by RECIST 1.1

To evaluate anti-tumor activity of oregovomab added to niraparib by Disease Control Rate, defined as the portion of subjects with complete response (CR), partial response (PR) and stable disease (SD) at week 24. The DCR will be determined as defined by RECIST 1.1

Frequency of adverse events (AEs), serious adverse events (SAEs), deaths and AEs leading to discontinuation of treatment as defined by CTCAE version 5.0.

A. Change in baseline from week 1 to week 24 the frequency of vital signs taken.

Change in baseline from week 1 to week 24 the severity of vital sign measurements.

Humoral immune response measured by HAMA at week 7 relative to baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.	NCT05335993	Recurrent Ovari... Recurrent Epith... Recurrent Epith... Recurrent Fallo... Peritoneal Canc... Recurrent Carci... Adenocarcinoma ...	Oregovomab Niraparib	18 Years - 99 Years	CanariaBio Inc.
A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.	NCT05335993	Recurrent Ovari... Recurrent Epith... Recurrent Epith... Recurrent Fallo... Peritoneal Canc... Recurrent Carci... Adenocarcinoma ...	Oregovomab Niraparib	18 Years - 99 Years	CanariaBio Inc.

Spots Global Cancer Trial Database for recurrent epithelial cancer of ovary