Neo-adjuvant Pembrolizumab in Primary Stage IV Ovarian Cancer

NCT03126812 | Completed Phase 1

• 1 other identifier: N16OPE
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm feasibility study in patients with primary FIGO stage IV serous ovarian, peritoneal, or fallopian tube cancer to evaluate neo-adjuvant + adjuvant pembrolizumab for its capacity to induce and broaden T cell responses against tumor neo-antigens.

Conditions

Ovarian Cancer Stage IV; Peritoneal Cancer; Fallopian Tube Cancer

Keywords

Primary stage 4; Neo adjuvant

Outcome Measures

Primary Outcomes (1)

• Number of T-cells in peripheral blood

  determine the number of T cells in peripheral blood samples and tissue samples

  up to week 52

Secondary Outcomes (3)

• Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0

  up to 30 days after end of treatment

• Response Rate

  at week 12, debulking surgery

• Response rate according to RECIST

  at week 3 and 6

Study Arms (1)

Carboplatin, paclitaxel, pembrolizumab

EXPERIMENTAL

Carboplatin AUC= 6 paclitaxel 80 mg/m2 Pembrolizumab 200 mg starting cycle 2

Drug: Carboplatin; Drug: Paclitaxel; Drug: Pembrolizumab

Interventions

Carboplatin DRUG

Carboplatin AUC=6

Carboplatin, paclitaxel, pembrolizumab

Paclitaxel DRUG

paclitaxel 80 mg/m2

Carboplatin, paclitaxel, pembrolizumab

Pembrolizumab DRUG

200 mg flat dose, starting cycle 2

Carboplatin, paclitaxel, pembrolizumab

Eligibility Criteria

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

You may qualify if:

• Written informed consent for the trial.
• Diagnosis of primary stage IV high-grade serous ovarian, peritoneal, or fallopian tube cancer.
• Age \>= 18 years on day of signing informed consent.
• Willing and able to provide three tumor biopsies (1 FFPE, 2 fresh frozen) prior to start of treatment
• Performance status of 0 or 1 on the ECOG Performance Scale.
• Adequate organ function as defined in Table 1 of the protocol
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

You may not qualify if:

• Previously received treatment for ovarian, peritoneal, or fallopian tube cancer.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
• Known additional malignancy, unless treated with curative intent without chemotherapy at least five years ago. In situ cancers, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have undergone potentially curative therapy within the past five years may also be eligible.
• Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• A known history of active TB (Bacillus Tuberculosis)
• Hypersensitivity to pembrolizumab or any of its excipients.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Carboplatin; Paclitaxel; pembrolizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: April 24, 2017
• Study Start: November 1, 2017
• Primary Completion: June 1, 2023
• Study Completion: March 5, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

NL (1)