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High Grade Serous OvarianPhase 1NCT03245892

A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer

A Phase 1 study testing Carboplatin and Paclitaxel, Nivolumab and Cytoreductive surgery in people with High Grade Serous Ovarian and Fallopian Tube, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out what effects, good or bad, the addition of nivolumab or the combination of nivolumab plus ipilimumab to typical chemotherapy has on the treatment of advanced high-grade serous cancers of ovarian, fallopian tube, or primary peritoneal origin. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Carboplatin and Paclitaxel, Nivolumab and Cytoreductive surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
4 Aug 2017to 4 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have clinically and radiographically suspected International Federation of Gynecology and Obstetrics (FIGO) stage (Appendix 2) 3 or 4 high grade serous ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS). Patients will be selected for NACT according to established criteria (Society of Gynecologic Oncology and the American Society of Clinical Oncology Guideline, https://www.ncbi.nlm.nih.gov/pubmed/27650684). Patients must have undergone core needle biopsy for histologic confirmation prior to start of treatment. See Appendix 3 for guidelines to aid in histologic diagnosis.
  • Institutional confirmation of pathology on or laparoscopic biopsy performed at MSKCC with sufficient tissue for analysis or willingness to undergo repeat laproscopic biopsy if diagnostic biopsy was performed at an outside hospital.
  • Appropriate stage for study entry based on the following diagnostic workup:
  • History/physical examination within 28 days prior to registration;
  • CT imaging of the chest, abdomen and pelvis within 28 days prior to registration documenting disease consistent with FIGO stage III or IV disease (patients who cannot receive contrast may instead undergo MRI of abdomen and pelvis along with non-contrast chest CT);
  • Further protocol-specific assessments as detailed below.
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  • Age ≥18
  • ECOG Status of 0, 1, or 2 within 28 days prior to registration.
  • Adequate hematologic function within 14 days prior to registration defined as follows:
  • ANC ≥1,000/mcl. This ANC cannot have been induced by granulocyte colony stimulating factors.
  • Platelets ≥75,000/mc
  • Hemoglobin ≥8.0 mg/dl (transfusions are permitted to achieve baseline hemoglobin level)
  • Adequate renal function within 14 days prior to registration defined as follows:
  • °Creatinine <=1.5 x ULN.
  • Adequate hepatic function within 14 days prior to registration defined as follows:
  • Bilirubin ≤ 1.5 x ULN
  • ALT and AST ≤ 3 x ULN
  • Alkaline phosphatase ≤ 2.5 x ULN
  • For patients with Gilbert's syndrome, Bilirubin ≤ 3 xULN is acceptable.
  • Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1.
  • Adequate thyroid function within 14 days prior to registration defined as serum TSH within the normal range.
  • The patient or legally authorized representative must provide study-specific informed consent prior to study entry.

Who cannot join

  • Subjects with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 3 years. Subjects are also excluded if their previous cancer treatment contraindicates this protocol's therapy.
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded. Prior radiation for localized cancer of the breast, head and neck or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • Patients who have received any prior treatment for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer.
  • Patients with any histology other than high grade serous evident on pretreatment biopsy.
  • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: Stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including serous, clear cell or other FIGO grade 3 lesions.
  • Severe, active co-morbidity defined as follows:
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  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment (with the exception of uncomplicated UTI)
  • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association Class III or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate).
  • Partial or complete gastrointestinal obstruction
  • Patients with anticipated contraindications to interval tumor reductive surgery.
  • Patients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocol.
  • Patients who are unwilling to be transfused with blood components.
  • Concurrent anticancer non protocol directed therapy (e.g. chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy).
  • Receipt of an investigational study drug for any indication within 28 days or 5 half-lives (whichever is longer) prior to Day 1 of protocol therapy.
  • Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations.
  • Patients who are pregnant or nursing. The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test within 7 days of study enrollment, prior to dosing nivolumab, then every 6 weeks. After discontinuation from nivolumab these should be repeated at approximately 30 days and approximately 70 days. Women must not be breastfeeding.
  • Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception.
  • Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40mIU/mL.
  • Patients are excluded if they have active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 4 weeks or more after treatment is complete and within 28 days prior to the first dose of nivolumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
  • In order for patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) to be eligible, they must be on a stable highly active antiretroviral therapy (HAART) regimen, have CD4 counts > 350, with no detectable viral load on quantitative PCR.
  • Patients with treated hepatitis virus infections (Hepatitis B or Hepatitis C) are eligible if they have been definitively treated for 6 months, have no detectable viral load on quantitative PCR, and LFTs meet eligibility requirements.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  • Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement (such as Hashimoto's thyroiditis), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
  • Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses <10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
  • Any of the following within 2 months of registration: active peptic ulcer disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, malabsorption syndrome. Any of the following within 6 months of registration: Intra-abdominal abscess, gastrointestinal obstruction requiring parenteral hydration and/or nutrition, gastrointestinal perforation. Note: complete resolution of an intra-abdominal abscess must be confirmed prior to registration even if the abscess occurred more than 6 months prior to registration.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Pilot Study of Nivolumab With or Without Ipilimumab in Combination With Front-Line Neoadjuvant Dose Dense Paclitaxel and Carboplatin Chemotherapy and Post-Surgical Dose Dense Paclitaxel and Carboplatin Chemotherapy in Patients With High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The purpose of this study is to find out what effects, good or bad, the addition of nivolumab or the combination of nivolumab plus ipilimumab to typical chemotherapy has on the treatment of advanced high-grade serous cancers of ovarian, fallopian tube, or primary peritoneal origin. The typical chemotherapy treatment is Carboplatin and Paclitaxel.

Being tested
Carboplatin and Paclitaxel, Nivolumab, Cytoreductive surgery, Ipilimumab
Keywords
Nivolumab, Paclitaxel, Carboplatin, 17-182

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carboplatin and PaclitaxelDrug

    Paclitaxel 80mg/m2 will be administered over approximately 1 hour as an IV infusion on Days 1,8, and 15 of each 21-day cycle. Carboplatin AUC6 will be administered as approximately a 30 minute IV infusion, following paclitaxel administration on Day 1 of each 21-day cycle.

  • NivolumabDrug

    Nivolumab 360mg will be infused IV over approximately 30 min on Day 1 of Cycles 1-6 (to 8) of each 21 day cycle. During the maintenance phase, Nivolumab 480mg will be infused IV over approximately 30 min on day 1 of each 28 day cycle, for up to 12 months. During the maintenance period, each cycle is 4 weeks

  • Cytoreductive surgeryProcedure or surgery

    Cytoreductive surgery

  • IpilimumabDrug

    Ipilimumab 1mg/kg every 6 weeks x 3-6 cycles in the neoadjuvant setting (maximum 2 doses of ipilimumab)

Study groups in NCT03245892
Study groupRoleWhat they receive
Carboplatin and Paclitaxel Chemotherapy With Nivolumab (Closed)ExperimentalPatients will be treated with nivolumab plus standard of care dose dense paclitaxel and carboplatin for three cycles, where each cycle is 3 weeks, followed by cytoreductive surgery then three more cycles of the same treatment regimen administered as adjuvant treatment. Paclitaxel 80mg/m2 will be administered over approximately 1 hour as an IV infusion on Days 1,8, and 15 of each 21-day cycle. Carboplatin AUC6 will be administered as approximately a 30 minute IV infusion, following paclitaxel administration on Day 1 of each 21-day cycle. Carboplatin dose calculation instructions can be found in Appendix 4. Nivolumab 360mg will be infused IV over approximately 30min on Day 1 of Cycles 1-6. During the maintenance phase, Nivolumab 480mg will be infused IV on day 1 of each 28 day cycle, for up to 12 months. During the maintenance period, each cycle is 4 weeks.
Receives: Drug: Carboplatin and Paclitaxel; Drug: Nivolumab; Procedure: Cytoreductive surgery
Nivolumab plus Ipilimumab plus Paclitaxel & CarboplatinExperimentalPatients will be treated with nivolumab plus ipilimumab plus standard of care dose dense paclitaxel \& carboplatin chemotherapy for 3 cycles (up to a maximum of six), each cycle is 3 weeks, followed by cytoreductive surgery then three more cycles of the same treatment regimen. Paclitaxel 80mg/m2 IV will be administered over approx 1 hour on Days 1,8, \& 15 of each 21 day cycle. Carboplatin AUC6 will be administered as an approx 30 minute IV infusion, following paclitaxel admin on Day 1 of each 21 day cycle. Nivolumab 360mg will be infused IV over approx 30 min on Day 1 of Cycles 1-6 (to 9) of each 21 day cycle. Ipilimumab 1mg/kg will be infused IV over approx 30 min on Day 1 of Cycles 1 \& 3, as well as Cycle 4 \& Cycle 6. Of note, if patients receive more than 3 cycles in the pre-operative setting, then ipilimumab will be administered with the first \& third cycle in the post-operative setting. Nivolumab will then be infused Day 1 of each 28 day maintenance phase cycle.
Receives: Drug: Carboplatin and Paclitaxel; Drug: Nivolumab; Procedure: Cytoreductive surgery; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of patients with dose limiting toxicities with weekly paclitaxel/carboplatin plus nivolumab

    The safety of this regimen will be assessed by determination of the DLTs observed in the study population. If >=3/10 DLTs are seen we will deem the regimen not safe and stop the trial early. If >=5/20 patients have DLTs the treatment regimen would be deemed unsafe. Enrollment will be halted after 10 patients have accrued until all 10 patients have cleared the DLT period of 6 weeks

    Measured: 6 weeks

  2. number of patients with dose limiting toxicities weekly paclitaxel/carboplatin plus nivolumab and ipilimumab

    The safety of this regimen will be assessed by determination of the DLTs observed in the study population. If >=3/10 DLTs are seen we will deem the regimen not safe and stop the trial early. If >=5/20 patients have DLTs the treatment regimen would be deemed unsafe. Enrollment will be halted after 10 patients have accrued until all 10 patients have cleared the DLT period of 6 weeks

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2017
  2. Study start4 Aug 2017
  3. Primary completion4 Dec 2025
  4. Study completion4 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Single center, non-randomized, open label, pilot study to evaluate the safety and tolerability of neoadjuvant and post-surgical dose dense paclitaxel and carboplatin chemotherapy in combination with nivolumab for the treatment of advanced high grade serous cancers of ovarian, fallopian tube, or primary peritoneal origin.
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03245892
Sponsor's protocol ID
17-182
Status last verified
Dec 2025
First submitted
8 Aug 2017
Last updated
17 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Moufarrij S, Friedman CF, Freeman S, Green H, Abu-Rustum NR, Broach V, Chi DS, Cohen S, Gardner G, Grisham RN, Iasonos A, Leitao MM Jr, Long K, Park K, Tew W, Wibmer A, Zhou Q, Aghajanian C, Weigelt B, Zamarin D, O'Cearbhaill RE. A pilot study of nivolumab in combination with neoadjuvant and post-surgical chemotherapy in newly diagnosed ovarian cancer. Gynecol Oncol. 2025 Dec;203:97-104. doi: 10.1016/j.ygyno.2025.10.020. Epub 2025 Oct 31.

    PubMed 41175449

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Carboplatin and Paclitaxel, Nivolumab and Cytoreductive surgery in people with High Grade Serous Ovarian and Fallopian Tube, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of patients with dose limiting toxicities with weekly paclitaxel/carboplatin plus nivolumab (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03245892, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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