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Protocol Details

Phase II Evaluation of Nivolumab, an Immune Checkpoint Inhibitor, alone or in combination with Oral Decitabine/Tetrahydrouridine as Second Line Therapy for Non-Small Cell Lung Cancer

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-C-0052

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

No

Population Exclusion(s)

Pregnant Women;
Fetuses;
Children

Keywords

Lung Cancer;
p53;
Immune Checkpoint Inhibitor;
DNMT1;
Solid Cancer Tissues

Recruitment Keyword(s)

None

Condition(s)

Non-Small Cell Lung Cancer

Investigational Drug(s)

Decitabine
Tetrahydrouridine

Investigational Device(s)

None

Intervention(s)

Drug: Decitabine (DEC)
Drug: Tetrahydrouridine (THU)
Drug: Nivolumab

Supporting Site

National Cancer Institute

Background:

Lung cancer is the leading cause of cancer related mortality in the United States. The drug decitabine (Dec) blocks an enzyme that is often increased in cancer. This could reduce tumor formation. The drug tetrahydrouridine (THU) blocks an enzyme that breaks down Dec. This increases the time cells are exposed to Dec. The drug nivolumab blocks a signal that prevents white blood cells from attacking cancer. This allows the immune system to attack the tumor.

Objective:

To test if treatment with THU and Dec with nivolumab is more effective than treatment with nivolumab alone in people with non-small cell lung cancer (NSCLC).

Eligibility:

People ages 18 and older with NSCLC that is not shrinking with known therapies

Design:

Participants will be screened with:

-Medical history

-Physical exam

-Blood and urine tests

-Tumor biopsy: A small piece a tumor is removed with a needle.

-CT or MRI scan

Participants will be randomly assigned to 1 of 2 study groups. They will have treatment in 28-day cycles:

-Group 1: THU and Dec 2 days in a row each week

-Groups 1 and 2: Nivolumab by vein on days 1 and 15 of each cycle. They will have blood tests and physical exams on these days. They will have additional blood tests on Day 2 of Cycle 1. They will have scans every other cycle. They may have additional biopsies. They will keep a drug diary.

Participants will continue treatment until their disease progresses. After they stop treatment, they will have a final visit. Then they will be evaluated every 12 weeks.

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Eligibility

INCLUSION CRITERIA:

-Patients with measurable histologically or cytologically proven Non-Small Cell Lung Cancer (NSCLC)

-Subjects must have received 1 or more prior systemic therapies for this disease, (this can include neo-adjuvant or adjuvant chemotherapy if administered <2years prior to study enrollment), should not have had prior treatment with immunotherapy; (including immune checkpoint inhibitor drugs, or immunotherapy vaccines)

-Willing and able to undergo bronchoscopic, surgical or percutaneous biopsy (may be eligible if archival tissue from a biopsy is after most recent therapy or if the risks of biopsy are judged to be excessive by the study PI).

-Male or female greater than or equal to 18 years

-ECOG performance status of 0 - 2

-Patients must have adequate organ and marrow function

EXCLUSION CRITERIA:

-Patients who are receiving any other investigational agents concomitantly.

-Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 2 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.

-Has had prior chemotherapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events related to treatment. Palliative radiation therapy within 1 week prior to study Day 1 is allowed. Patients on targeted therapy may start study treatment 5 days from last treatment. Adequate recovery from a major surgery is required.

-Has a known secondary malignancy.

-Has active or documented history of autoimmune disease requiring systemic therapy in the preceding 2 years. Patients with psoriasis and rheumatoid arthritis with no evidence of disease flare off immunosuppression for >1year may be allowed after discussion with the study PI.

-Has a known history of HIV or active Hepatitis B.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

David S. Schrump, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3942
10 CENTER DR
BETHESDA MD 20892
(240) 760-6239
david_schrump@nih.gov

Lydiah Mutumbi
National Cancer Institute (NCI)
BG 10-CRC RM 6-5140
10 CENTER DR
BETHESDA MD 20814
(240) 858-7562
lydiah.mutumbi@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT02664181

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