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Protocol Details

A Phase 1 Study of Intraperitoneal MCY-M11 Therapy for Women with Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects with Peritoneal Mesothelioma with Recurrence after Prior Chemotherapy

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women


CAR-T Cell Therapy;

Recruitment Keyword(s)



Ovarian Cancer;
Fallopian Tube Cancer;
Peritoneal Cancer

Investigational Drug(s)


Investigational Device(s)



Biological/Vaccine: MCY-M11
Drug: Cyclophosphamide

Supporting Site

National Cancer Institute


A new cancer treatment uses a person s immune system cells to target cancer. White blood cells are collected and sent to a lab. Genetic material is injected into the cells, which may allow the cells to target tumors. The cells are returned to the person as the drug MCY-M11. Researchers want to see if MCY-M11 helps people with certain cancers.


To determine the highest safe dose of MCY-M11.


Adults at least 18 years old with a certain ovarian cancer or peritoneal mesothelioma not helped by standard therapies


Participants will be screened with:

Medical history

Physical exam

Mental health questionnaire

Daily activities assessment

Blood, urine, and heart tests


Participants will have a catheter placed in the abdomen.

Participants will repeat screening tests. They may have blood oxygen levels tested.

Participants will have leukapheresis. Blood will be removed by a catheter from a vein. A machine will collect white blood cells. The rest of the blood will be returned by a needle in the other arm.

Participants cells will be changed and tested in a lab.

Participants will stay in the hospital 9 days.

They will get the study drug via catheter 2 times.

Some screening tests will be repeated.

Any fluid in the abdomen will be collected and tested.

Participants will get a 3rd dose of the study drug a few days after leaving the hospital.

Participants will have 6 follow-up visits over about a month, then once every month. They will repeat some screening tests.

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-Patients greater than or equal to 18 years of age.

-Patients must be able to undergo peripheral blood leukapheresis of peripheral blood mononuclear cells (PBMC) during the screening


-Patients must have successful placement of an intraperitoneal catheter/port for IP delivery.

-Patients with either of the following diagnoses:

--metastatic or unresectable high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube with peritoneal involvement. Mixed histologies will not be allowed.

---Patients with recurrent or refractory epithelial ovarian, primary peritoneal or fallopian tube carcinoma, who have received platinum containing chemotherapy and either has platinum refractory or resistant disease (relapsed within 6 months of prior platinum containing chemotherapy), or, if platinum sensitive disease, have received greater than or equal to 2 lines of chemotherapy. Patients may have received PARP inhibitors, bevacizumab, or immunotherapy.

---Patients with germline BRCA mutations must have progressed or been intolerant of PARP inhibitor therapy.

---Patients must have measurable or evaluable disease involving the peritoneal cavity by any of these criteria:

1. Measurable disease according to RECIST v1.1 / iRECIST.

2. Evaluable disease includes either ascites, or peritoneal carcinomatosis with and without CA 125.

3. Patients with peritoneal disease who also have disease involving the pleural cavity or distant metastases will be eligible as long as they have measurable or evaluable disease in the peritoneal cavity.

---Diagnosis must be confirmed by either pathological study of initial disease or recurrent disease.

--epithelioid or biphasic peritoneal mesothelioma not amenable to potentially curative surgical resection. However, patients with biphasic tumors that have a >50% sarcomatoid component will be excluded.

---Patients must have had at least one prior chemotherapy regimen that includes pemetrexed and cisplatin or pemetrexed and carboplatin.

---There is no limitation for the number of prior therapies allowed.

---Diagnosis must be confirmed by either pathological study of initial disease or recurrent disease.

---Patients must have measurable or evaluable disease involving the peritoneal cavity by any of these criteria:

1. Measurable disease according to RECIST v1.1 / iRECIST.

2. Evaluable disease includes either CA 125, ascites, or peritoneal carcinomatosis.

3. Patients with peritoneal disease who also have disease involving the pleural cavity or distant metastasis will be eligible as long as they have measurable or evaluable disease in the peritoneal cavity.

-Patients must be at least 4 weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy, immunotherapy and monoclonal antibodies, -alternative therapy or investigational -therapeutic -agents including prior IP therapy) before the start of therapy on Day 1. Patients who have had cranial radiation therapy need to have completed it more than 4 weeks prior to commencing -start of therapy on Day 1. Pre-leukapheresis, patients should not be receiving active anti-cancer therapy. If active cancer therapy has been recently received, then approximately 2 weeks should pass without active cancer therapy prior to leukapheresis and the patient should have full recovery of labs and AEs related to the cancer therapy

-Patients who have had major surgery must be fully recovered and require a recovery period of greater than or equal to 4 weeks prior to start of therapy on Day 1.

-Patients must have archival tumor available for correlative studies.

-Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.

-Mini-mental status exam (MMSE) score equal to or greater than 24 of 30.

-Patients must have adequate organ and marrow function (as defined below).

--serum creatinine less than or equal to 1.5 X upper limit of normal (ULN), or measured creatinine clearance greater than or equal to 60 ml/min/1.73m(2). If urinary tract obstruction is present, it should be corrected before treatment with cyclophosphamide.

--aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than or equal to 3 X ULN.

--total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert s syndrome who should have a total bilirubin of less than 3 X ULN.

--absolute neutrophil (ANC) greater than or equal to 1,500/mm(3).

--platelet count greater than or equal to 100,000/mm(3),

--hemoglobin greater than or equal to 10 mg/dL (transfusion to obtain hemoglobin greater than or equal to 10 mg/dL is allowed).

--Total WBC >=3,000/mm3.

-Men and women who are able to become pregnant or impregnate a partner must agree to use adequate contraception (barrier method or abstinence) for the duration of study therapy and for 3 months after the last dose of MCY-M11. Any pregnancy that occurs for study participants should be monitored for potential side effects. Women should discontinue any hormonal forms of birth control at least 4 weeks prior to initiating the study.

-Able to understand and voluntarily sign a written informed consent, and are willing and able to comply with the protocol requirements.

-Life expectancy greater than 3 months.


A patient t will be excluded from study for any one of the following criteria:

-Diagnosis of human immunodeficiency virus (HIV) or chronic active hepatitis B or C. Viral testing is required to be performed with negative results during the screening period or within four weeks prior to the screening period

--The reason for exclusion is insufficient evidence demonstrating safety of administration of MCY-M11 in patients with HIV, hepatitis B or C due to theoretical risk of unmasking or exacerbating these serious viral illnesses since MCY-M11 may impair immunological function. Data are not currently available on risk of interaction with antiretroviral drugs. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MCY- M11. The potential immune suppressive effects and T-cell depletion associated with MCY-M11 pose an additional increased risk to these patients. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

-Symptomatic or uncontrolled brain metastases (including leptomeningeal metastases) requiring current treatment (4 weeks from last cranial radiation or <4 weeks from last steroids). Patients with abnormal clinical exam or history will require a head CT or MRI to rule out or confirm brain metastases.

-Impaired cardiac function or clinically significant cardiac disease including the following:

--New York Heart Association grade III or IV congestive heart failure.

--Myocardial infarction within the last 12 months prior to dosing with MCY-M11.

--Patients with impaired left ventricular ejection fraction (LVEF) as assessed by echocardiography according to institutional standards must be excluded.

-Lack of recovery of prior adverse events (AEs) to Grade less than or equal to l severity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v 5.0) (except alopecia) due to therapy administered prior to the initiation of Investigational Product dosing. Stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the Investigator as MCY-M11 has not been shown to cause or exacerbate peripheral neuropathy.

-Patients with a known allergy to any of the formulation components of MCY-M11. For patients receiving cyclophosphamide, known severe hypersensitivity reaction to it, any of its metabolites, or to other components of the product.

-Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 14 days from completion of antibiotics or when symptoms have resolved, at the discretion of the study investigator.

-Another previous or current malignancy within the last 3 years, with the exception of non-melanoma skin cancer, cervical carcinoma in situ curatively treated, ductal or lobular carcinoma in situ curatively treated and without ongoing therapeutic intervention. Patients with breast cancer susceptibility gene (BRCA) 1 or 2 mutation, who have had a previous diagnosis of breast cancer are eligible if the breast cancer was diagnosed 5 years previously and distant or local recurrence of breast cancer has been ruled out.

-Concomitant chronic (daily or almost daily for greater than or equal to 1 month prior) use of steroids or non-steroidal anti-inflammatory drugs (NSAIDS). Intermittent use of steroids as pre-medications is allowed.

-No concomitant use of complementary or alternative medication or other agents (investigational therapeutic agents) will be allowed without approval of a principal investigator (PI) or sub-investigator (SI). Every effort will be made to maximize patient safety and minimize changes in chronic medications.

-Prior immune cell therapies (i.e. CAR-Ts, TCR, etc) will be excluded. Standard of care bone marrow or stem cell transplants are allowed.

-Patients with a recent history (within last 5 years) of autoimmune disease (excluding endocrine autoimmune disease treated with replacement therapy) or inflammatory diseases will be excluded, for example, active rheumatoid arthritis, active inflammatory bowel disease, or any chronic inflammatory conditions because MCY-M11 may exacerbate T-cell responses. Patients with persistent

autoimmune side effects of prior immune therapies (i.e. checkpoint inhibitors) will also be excluded. Eligibility for patients with prior severe autoimmune AEs will be discussed between the sponsor and the investigator on a case by case basis. Prior history of severe side effects with prior immune therapies such as carditis, pneumonitis, hepatitis, colitis, encephalitis will be excluded.

-Any other condition or finding that in the opinion of the investigator or Sponsor Medical Monitor may render the patient at excessive risk for treatment complications or may not be able provide evaluable outcome information.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Kevin C. Conlon, M.D.
National Cancer Institute (NCI)
(240) 760-6087

Miroslava Pavelova, C.R.N.P.
National Cancer Institute (NCI)
(240) 858-3241

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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