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Retrospective analysis of all patients diagnosed, from 01/01/2000 to 01/01/2014, with low-grade serous ovarian cancer or invasive recurrence after surgery for borderline serous carcinoma

Francesco Perrone, MD PhD

Teresa Ribecco, PhD

Sandro Pignata, MD PhD

Chiara Della Pepa, MD

The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy.

Archival tissue tumor samples in paraffin blocks for evaluation of diagnosis and biomarkers

Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer

National Cancer Institute, Naples

Antineoplastic Agents

Fulvestrant

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Oral regorafenib in a ReDOS plan (80 mg week#1, 120 mg week#2, 160 mg week#3 for cycle #1 then adjust final dose for subsequent cycles based on tolerance during cycle #1) \[3 weeks on/1 week off\] combined with intramuscular injection of fulvestrant 500 mg day #1 (day #15 will be planned only in cycle #1) in a 28-day cycle till disease progression or unacceptable toxicities

Oral regorafenib in a ReDOSplan (80 mg week#1, 120 mg week#2, 160 mg week#3 for cycle #1 then adjust final dose for subsequent cycles based on tolerance during cycle #1) \[3 weeks on/1 week off\] combined with intramuscular injection of fulvestrant 500 mg day #1 (day #15 will be planned only in cycle #1) in a 28-day cycle till disease progression or unacceptable toxicities

Regorafenib

500 mg day #1 (day #15 will be planned only in cycle #1) in a 28-day cycle till disease progression or unacceptable toxicities

Sarah Lynam, MD

Nancy Fusco, RN

Sarah M Lynam, MD

To see how effective the study medicine combined with hormone therapy is when given to participants with recurrent low-grade serous ovarian cancer.

Regorafenib is an investigational drug that works by interrupting the rapid and uncontrolled growth of cancer cells by stopping the signals that tell the cancer cells to grow and the ability of the cancer cells to form new blood vessels which they need to be able to grow.

Treatment will continue until disease progression or unacceptable toxicities. For participants with a complete response to therapy, maintenance therapy with both drugs will be continued for 12 months.

Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer

Efficacy of Oral Regorafenib Combined With Intra-muscular Injection of Fulvestrant in Patients With Recurrent Low-grade Serous Ovarian Cancer: A Phase II Single Arm Trial

Individual participant data that underlie or influence the results observed in this study

Translational research component to identify genomic related markers that can predict response and/or resistance to the combined therapy. Archival tumor tissue will be utilized as baseline. Peripheral blood will be obtained at time of start of treatment (baseline), C2D1 (4 weeks), C3D1 (8 weeks), and C4D1 (12 weeks) and at time of progression.

To assess the efficacy of this regimen in term of overall objective response rate (complete response rate) at 12 weeks as assessed by the Investigator, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).

The number of participants that reach a complete response (CR) defined as normalization of tumor markers, tumor nodes \<10 mm.

To assess the efficacy of this regimen in term of overall objective response rate (partial response rate) at 12 weeks as assessed by the Investigator, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).

The number of participants that reach a partial response (PR)defined as at least a 30% decrease in the sum of diameters of target lesions.

To assess overall survival in months from enrollment to date of last follow up or death. The number of participants still alive at end of study.

To assess progression-free survival in months from enrollment to date of documented disease progression or death. The number of participants still alive at end of study.

To assess clinical benefit rate (objective response and stable disease)at 12 weeks.

The number of participants that have grade 3 and 4 related toxicities. Adverse Events will be characterized by type, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v.5.03), timing, seriousness, and relationship to study therapy.

Bayer

Sarah K. Lynam MD

Principal Investigator, MD

Digestive System Diseases

Pancreatic Neoplasms

Pancreatic Cancer

Single dose of 3.3x10(12) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14.

Single dose of 1x10(13) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14.

In the event that 2 DLTs occur in Cohort 1, then enrollment in Cohort 1 will be stopped and Cohort -1 will be opened for evaluation. Enrolled subjects will receive a single dose of huCART-meso cells on Day 0 followed by a single dose of 3.3x10(12) vp of VCN-01 on Day 14.

VCN-01

Intravenous administration of huCART-meso cells

huCART-meso Cells

Abramson Cancer Center Clinical Trials Services

Abramson Cancer Center Clinical Trials Service

Janos L. Tanyi, MD, PhD

This is a Phase I study evaluating the safety and feasibility of lentiviral transduced huCART-meso cells when given in combination with VCN-01 in a 3+3 dose (de)escalation design.

This is a Phase I study evaluating the safety and feasibility of lentiviral transduced huCART-meso cells when given in combination with VCN-01 in a 3+3 dose (de)escalation design as follows:

* Cohort 1 (N = 3-6): will receive VCN-01 as a single IV infusion of 3.3x1012 vp on Day 0, followed by a single dose of 5x107 huCART-meso cells on Day 14 via IV infusion. This cohort will be evaluated as follows:

  * If 1 DLT/3 subjects occurs, Cohort 1 will be expanded to enroll an additional 3 evaluable subjects.
  * If 0 DLT/3 subjects or 1 DLT/6 subjects, the study will advance to Cohort 2.
* Cohort 2 (N = 3-6): will receive VCN-01 as a single IV infusion of 1x1013 vp on Day 0 followed by a single dose of 5x107 cells huCART-meso cells on Day 14 via IV infusion. This cohort will be evaluated as follows:

  * If 0 DLT/3 subjects or 1 DLT/3 subjects occurs, Cohort 2 will be expanded to enroll an additional 3 evaluable subjects. If 0 DLT/6 subjects or 1 DLT/6 subjects occurs, this dose combination will be identified as the recommended phase 2 dose (RP2D).
  * If 2 DLTs occur at any time, enrollment in this Cohort will be stopped. If less than 6 subjects were infused in Cohort 1 prior to Cohort 2 escalation, additional subjects will be enrolled in Cohort 1to reach a minimum of 6 evaluable subjects.

In the event that 2 DLTs occur in Cohort 1, then enrollment in Cohort 1 will be stopped and Cohort -1 will be opened for evaluation. Cohort -1 will evaluate a different sequence of administration for these two investigational products at the same dose level used in Cohort 1.

• Cohort -1 (N = up to 6): will receive a single dose of 5x107 huCART-meso cells via IV infusions on Day 0 followed by VCN-01 as a single infusion of 3.3x1012 vp on Day 10. Up to 6 subjects will be infused in Cohort -1 unless \> 1 DLTs are observed at any time.

The Day 0 infusions of the first two subjects in each cohort will be staggered by at least 42 days from the prior subject's 1st infusion (huCART-meso or VCN-01; depending on the cohort assignment), to allow for the assessment of DLTs and a formal decision regarding cohort progression, expansion, or de-escalation. Subsequent subject infusions within that cohort will be staggered by at least 14 days from the preceding subject's second infusion. Formal DLT assessments will be performed by the Clinical PI and Sponsor Medical Director in accordance with the definition provided in the protocol.

huCART-meso + VCN-01 in Pancreatic and Ovarian Cancer

Phase 1 Trial of Human Chimeric Antigen Receptor Modified T Cells (huCART-meso) Administered in Combination With VCN-01 in Patients With Pancreatic and Serous Epithelial Ovarian Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer	NCT02408536	Low-grade Serou... Recurrent Invas...		18 Years -	National Cancer Institute, Naples
Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer	NCT05113368	Ovarian Cancer Serous Ovarian ...	Regorafenib Fulvestrant	18 Years -	Case Comprehensive Cancer Center
Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer	NCT02408536	Low-grade Serou... Recurrent Invas...		18 Years -	National Cancer Institute, Naples
huCART-meso + VCN-01 in Pancreatic and Ovarian Cancer	NCT05057715	Pancreatic Canc... Serous Ovarian ...	VCN-01 huCART-meso Cel...	18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for serous ovarian cancer