A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care

NCT04834544 | Recruiting Phase 2

• 1 other identifier: IOV12
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled,parallel-group preliminary verifying study about safety and efficacy of maintenance DCVAC/OvCa after first-line chemotherapy added to standard of care in patients with newly diagnosed FIGO III-IV ovarian, fallopian tube, or primary peritoneal carcinoma.

Conditions

Epithelial Ovarian Carcinoma; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival

  PFS defined as the time from randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression; progression will be assessed by the investigator per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

  From randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression, the follow up period is about 2 years.

Study Arms (2)

DCVAC/OvCa arm

EXPERIMENTAL

Combination Product: DCVAC/OvCa

Placebo arm

PLACEBO COMPARATOR

Combination Product: Placebo

Interventions

DCVAC/OvCa COMBINATION_PRODUCT

An active cellular immunotherapy product containing autologous dendritic cells that are generated ex vivo from patient's monocytes and apoptotic tumor cells prepared from tumor cell lines

DCVAC/OvCa arm

Placebo COMBINATION_PRODUCT

Placebo

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eighteen years of age or older at the time written informed consent is obtained
• Newly diagnosed, histologically confirmed FIGO stage III or IV EOC (high-grade serous or high-grade endometrioid)
• After primary debulking surgery or after interval debulking surgery; residual disease after surgery with optimal resection as R0 or R1 (R0 is defined as no macroscopic residual disease, R1 is defined as macroscopic residual disease with a maximal diameter of \<1 cm)
• Known BRCA status; if BRCA mutation status not known, results of BRCA testing must be available before randomization
• Laboratory criteria:
• White blood cells \>4000/mm3 (4.0×109/L) 5.2. Neutrophil count \>1500/mm3 (1.5×109/L) 5.3. Hemoglobin ≥8 g/dL (80 g/L) 5.4. Platelet count ≥100,000/mm3 (100×109/L) 5.5. Total bilirubin \<2× upper limit of normal (ULN) (benign hereditary hyperbilirubinemias, e.g., Gilbert's syndrome, are permitted) 5.6. Serum alanine aminotransferase, aspartate aminotransferase, and creatinine \<2×ULN 5.7. Blood urea nitrogen \<2×ULN
• Adequate coagulation parameters:
• Activated partial thromboplastin time ≤1.5×ULN 6.2. International normalized ratio ≤1.5
• ECOG performance status 0-2
• Patients of child-bearing potential and their partners who are sexually active must agree to the use of 2 highly effective forms of contraception from the patient's signing of the ICF until 6 months after the last/final dose of first-line Pt-based adjuvant chemotherapy or IMP, whichever occurs later:
• a. Condom with spermicide and one of the following:
• Oral contraceptive or hormonal therapy (e.g., hormone implants)
• Placement of an intra-uterine device (IUD)
• Acceptable non-hormonal birth control methods include:
• Total sexual abstinence from the patient's signing of the ICF until 6 months after the last/final dose of first-line Pt-based adjuvant chemotherapy or IMP, whichever occurs later

You may not qualify if:

• Non-epithelial ovarian carcinoma or mixed epithelial histology
• Borderline tumors (tumors of low malignant potential)
• First-line Pt-based adjuvant chemotherapy already started after surgery
• Intention to treat with intraperitoneal chemotherapy
• Previous or concurrent radiotherapy to the abdomen and pelvis
• Major surgery (with the exception of debulking surgery) within 3 weeks before informed consent signature or patient has not recovered from any effects of any major surgery
• Malignancy other than EOC, except malignancy that has been in complete remission for a minimum of 3 years and except carcinoma in situ of the cervix or non-melanoma skin carcinomas that have been definitively treated
• Use of any immunotherapy in the past (e.g., anti-PD-1/PD-L1 or other immune checkpoint inhibitors, therapeutic vaccines, adoptive cell therapy, cytokines); in case of uncertainty, discuss with the medical monitor
• Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for 28 days.
• Co-morbidities:
• Known hypersensitivity to any constituent of IMP
• Systemic immunosuppressive therapy for any reason (except inhaled / intranasal steroids and short-term systemic steroids \<30 days duration and ≤10 mg prednisone-equivalent per day are allowed)
• Participation in a clinical trial using experimental therapy within the last 4 weeks before informed consent signature
• Pregnant or breast feeding, or expecting to conceive children within the projected duration of the study treatment
• Refusal to sign informed consent

Sponsors & Collaborators

• Peking University Third Hospital: lead
• SOTIO a.s.: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Central Study Contacts

Yuan LI, Master

CONTACT

+86 18610689868; yuanli@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 8, 2021
• Study Start: April 19, 2021
• Primary Completion: October 20, 2024
• Study Completion (Estimated): April 20, 2027
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

CN (1)