A Phase II Study of Nivolumab in Patients With Genetic Alterations in DNA Damage Repair and Response Who Progressed After Standard Treatment for Metastatic Solid Cancers

NCT04761744 | Unknown Phase 2 DMC

• 1 other identifier: KM-06
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase II Study of Nivolumab in Patients with Genetic alterations in DNA Damage repair and response Who Progressed after Standard treatment for Metastatic Solid Cancers

Conditions

DDR Gene Mutation; Metastatic Solid Tumor

Keywords

Nivolumab

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  the percentage of patients experiencing confirmed complete response (CR) and partial response (PR) assessed by RECIST criteria v.1.1

  within maximum 3 years

Secondary Outcomes (2)

• Progression free survival

  within maximum 3 years

• Overall survival

  within maximum 3 years

Study Arms (1)

Nivolumab

EXPERIMENTAL

Drug: Nivolumab

Interventions

Nivolumab DRUG

Study treatment consists of nivolumab 3mg/kg, and will be repeated every 2 weeks.

Nivolumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has histologically and/or cytologically confirmed diagnosis of cancers in colon, stomach, biliary tract, breast, bladder and upper urinary tract, endometrium, ovarian, prostate, and other cancers.
• Alterations in DNA damage repair and response genes assessed by next-generation sequencing (K-MASTER panel assay of ≥370 genes)
• Progressed after at least first-line systemic chemotherapy for metastatic setting.
• ≥ 1 measurable lesion(s) by RECIST 1.1.
• Unresectable advanced or metastatic disease.
• Age over 20 years old.
• ECOG 0-1, but final decision by clinical.
• Adequate organ functions.
• Bone marrow function: Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1,500/mm3, platelet ≥ 100,000/mm3
• Hepatic functions: bilirubin ≤ 1.5 X ULN, AST/ALT ≤ 2.5 X ULN (≤ 5 X ULN in cases of liver metastasis)
• Renal functions: serum Cr ≤ 1.5 X ULN or calculated CCr (Cockroft) ≥ 30 ml/min
• Be willing and able to comply with the protocol for the duration of the study.
• Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw the study at any time, without prejudice.
• Female subjects must either be of non-reproductive potential (≥ 60 years old and no menses for ≥ 1 year without an alternative medical cause, or history of hysterectomy, or history of bilateral tubal ligation, or history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
• Women of childbearing potential and men must agree to use highly efficient contraception since signing of the IC form until at least 6 Month after the last study drug administration.

You may not qualify if:

• Any prior treatment with PD-1 or PD-L1 inhibitor.
• Receipt of the last dose of chemotherapy ≤ 28 days prior to the first dose of study drugs.
• Current or prior use of immunosuppressive medication within 28 days before the first dose of nivolumab, with the exceptions for the following:
• intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
• Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
• Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
• Concurrent or previous history of another primary cancer within 3 years prior to randomization except for curatively treated cervical cancer in situ, non-melanomatous skin cancer, superficial bladder cancer (pTis and pT1) and curatively treated thyroid cancer of any stage. Concurrent, histologically confirmed, unresected thyroid cancer without distant metastasis could be allowed with the agreement of the chief principal investigator.
• Uncontrolled CNS metastases; permitted if asymptomatic or neurologically stable.
• Prior radiation therapy would be permitted, but non-radiated evaluable lesions should be present at study entry.
• Radiation therapy during study treatment is not permitted, but if the local investigator decides that radiation therapy should be given during study treatments, he should be convinced that there is no evidence of disease progression with agreement of the chief principal investigator.
• Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
• Active or prior documented autoimmune disease within the past 2 years; subjects with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
• Active or prior documented inflammatory bowel disease.
• History of prior immunodeficiency.
• History of allogeneic organ transplantation.

Sponsors & Collaborators

• Korean Cancer Study Group: lead

Study Sites (2)

Korean Cancer Study Group

Seoul, Chongro-ku, 110999, South Korea

ACTIVE NOT RECRUITING

Korea University Anam Hospital

Seoul, Seongbuk-gu, Inchon-ro, 136-705, South Korea

RECRUITING

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MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kyong Hwa Park, MD, PhD

  Korean Cancer Study Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyong Hwa Park, MD, PhD

CONTACT

+821047617651; khpark@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: June 14, 2019
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)