DDR Gene MutationPhase 2NCT04761744
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
A Phase 2 study testing Nivolumab in people with DDR Gene Mutation and Metastatic Solid Tumor, run by Korean Cancer Study Group at 2 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- DDR Gene Mutation, Metastatic Solid Tumor
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 14 Jun 2019to Dec 2021
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- 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).
Show all 30Show fewer
- 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.
- Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3)
- Clinical diagnosis of active tuberculosis.
- Vaccination within 4 weeks of the first dose of nivolumab and while on trials is prohibited except for administration of inactivated vaccines
- Known history of testing positive for HIV
- Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive). Except, resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or Chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA <100IU/ml and must be on antiviral therapy)
- Major surgery or significant traumatic injury within 28 days prior to study treatment.
- Non-healing wound, ulcer, or bone fracture.
- Current evidence of significant gastrointestinal bleeding or (impending) obstruction.
- Concomitant participation in another clinical trial.
- Pregnant of breast-feeding subjects. Women of child-bearing potential must have pregnancy test within 7 days and a negative result must be documented before start of study treatment.
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
- Active infection requiring systemic therapy.
- Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
- Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Patient who can't comply with the protocol and who is not willing to comply with the protocol.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 1 recruiting
- Active, not recruiting
Korean Cancer Study Group
Seoul, Chongro-ku, 110999
- Recruiting
Korea University Anam Hospital
Seoul, Seongbuk-gu, Inchon-ro, 136-705
Kyong Hwa Park, MD, phD, +82-2-920-5983 ext. 5980, khpark@korea.ac.kr
About this study
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
Read the detailed description
All the patients will be included in the final analysis, with a total of 48 patients to be enrolled.
Treatment will occur until disease progression, unacceptable toxicity or patient withdrawal.
Study treatment consists of nivolumab 3mg/kg, and will be repeated every 2 weeks.
Response evaluation will be performed every 6 weeks (+/- 1 week window period is allowed).
- Conditions
- DDR Gene Mutation, Metastatic Solid Tumor
- Being tested
- Nivolumab
- Keywords
- Nivolumab
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Study treatment consists of nivolumab 3mg/kg, and will be repeated every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
the percentage of patients experiencing confirmed complete response (CR) and partial response (PR) assessed by RECIST criteria v.1.1
Measured: within maximum 3 years
Secondary outcomes (2)
Progression free survival
the time from study entry until the first observation of disease progression
Measured: within maximum 3 years
Overall survival
the time from study entry until death
Measured: within maximum 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start14 Jun 2019
- Primary completionMar 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for DDR Gene MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Cancer Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyong-Hwa, Park, Korean Cancer Study Group
- Investigators
- Kyong Hwa Park, MD, PhD, Principal investigator, Korean Cancer Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761744
- Sponsor's protocol ID
- KM-06
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oldham RK. Biologicals and biological response modifiers: fourth modality of cancer treatment. Cancer Treat Rep. 1984 Jan;68(1):221-32.
PubMed 6198081Waldmann TA. Immunotherapy: past, present and future. Nat Med. 2003 Mar;9(3):269-77. doi: 10.1038/nm0303-269. No abstract available.
PubMed 12612576Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
PubMed 26412456Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.
PubMed 27718784Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31.
PubMed 26027431Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.
PubMed 26406148Francisco LM, Sage PT, Sharpe AH. The PD-1 pathway in tolerance and autoimmunity. Immunol Rev. 2010 Jul;236:219-42. doi: 10.1111/j.1600-065X.2010.00923.x.
PubMed 20636820Okazaki T, Honjo T. The PD-1-PD-L pathway in immunological tolerance. Trends Immunol. 2006 Apr;27(4):195-201. doi: 10.1016/j.it.2006.02.001. Epub 2006 Feb 24.
PubMed 16500147Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol. 2008 Jun;8(6):467-77. doi: 10.1038/nri2326.
PubMed 18500231Hamanishi J, Mandai M, Iwasaki M, Okazaki T, Tanaka Y, Yamaguchi K, Higuchi T, Yagi H, Takakura K, Minato N, Honjo T, Fujii S. Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer. Proc Natl Acad Sci U S A. 2007 Feb 27;104(9):3360-5. doi: 10.1073/pnas.0611533104. Epub 2007 Feb 21.
PubMed 17360651Hino R, Kabashima K, Kato Y, Yagi H, Nakamura M, Honjo T, Okazaki T, Tokura Y. Tumor cell expression of programmed cell death-1 ligand 1 is a prognostic factor for malignant melanoma. Cancer. 2010 Apr 1;116(7):1757-66. doi: 10.1002/cncr.24899.
PubMed 20143437Ohigashi Y, Sho M, Yamada Y, Tsurui Y, Hamada K, Ikeda N, Mizuno T, Yoriki R, Kashizuka H, Yane K, Tsushima F, Otsuki N, Yagita H, Azuma M, Nakajima Y. Clinical significance of programmed death-1 ligand-1 and programmed death-1 ligand-2 expression in human esophageal cancer. Clin Cancer Res. 2005 Apr 15;11(8):2947-53. doi: 10.1158/1078-0432.CCR-04-1469.
PubMed 15837746Thompson RH, Kuntz SM, Leibovich BC, Dong H, Lohse CM, Webster WS, Sengupta S, Frank I, Parker AS, Zincke H, Blute ML, Sebo TJ, Cheville JC, Kwon ED. Tumor B7-H1 is associated with poor prognosis in renal cell carcinoma patients with long-term follow-up. Cancer Res. 2006 Apr 1;66(7):3381-5. doi: 10.1158/0008-5472.CAN-05-4303.
PubMed 16585157Nomi T, Sho M, Akahori T, Hamada K, Kubo A, Kanehiro H, Nakamura S, Enomoto K, Yagita H, Azuma M, Nakajima Y. Clinical significance and therapeutic potential of the programmed death-1 ligand/programmed death-1 pathway in human pancreatic cancer. Clin Cancer Res. 2007 Apr 1;13(7):2151-7. doi: 10.1158/1078-0432.CCR-06-2746.
PubMed 17404099Nakanishi J, Wada Y, Matsumoto K, Azuma M, Kikuchi K, Ueda S. Overexpression of B7-H1 (PD-L1) significantly associates with tumor grade and postoperative prognosis in human urothelial cancers. Cancer Immunol Immunother. 2007 Aug;56(8):1173-82. doi: 10.1007/s00262-006-0266-z. Epub 2006 Dec 22.
PubMed 17186290
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04761744
- Acronym / sponsor ID
- KM-06
- Conditions
- DDR Gene Mutation, Metastatic Solid Tumor
- Keywords
- Nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Korean Cancer Study GroupUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
All the patients will be included in the final analysis, with a total of 48 patients to be enrolled.
Treatment will occur until disease progression, unacceptable toxicity or patient withdrawal.
Study treatment consists of nivolumab 3mg/kg, and will be repeated every 2 weeks.
Response evaluation will be performed every 6 weeks (+/- 1 week window period is allowed).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: Nivolumab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (30 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabStudy treatment consists of nivolumab 3mg/kg, and will be repeated every 2 weeks. | Drug | Nivolumab |
Primary outcome
Objective response rate
Time frame: within maximum 3 years
the percentage of patients experiencing confirmed complete response (CR) and partial response (PR) assessed by RECIST criteria v.1.1
2 secondary outcomes
Progression free survival
Time frame: within maximum 3 years
Overall survival
Time frame: within maximum 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 6198081Oldham RK. Biologicals and biological response modifiers: fourth modality of cancer treatment. Cancer Treat Rep. 1984 Jan;68(1):221-32.
- Background: PubMed 12612576Waldmann TA. Immunotherapy: past, present and future. Nat Med. 2003 Mar;9(3):269-77. doi: 10.1038/nm0303-269. No abstract available.
- Background: PubMed 26412456Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
- Background: PubMed 27718784Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.
- Background: PubMed 26027431Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31.
- Background: PubMed 26406148Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.
- Background: PubMed 20636820Francisco LM, Sage PT, Sharpe AH. The PD-1 pathway in tolerance and autoimmunity. Immunol Rev. 2010 Jul;236:219-42. doi: 10.1111/j.1600-065X.2010.00923.x.
- Background: PubMed 16500147Okazaki T, Honjo T. The PD-1-PD-L pathway in immunological tolerance. Trends Immunol. 2006 Apr;27(4):195-201. doi: 10.1016/j.it.2006.02.001. Epub 2006 Feb 24.
- Background: PubMed 18500231Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol. 2008 Jun;8(6):467-77. doi: 10.1038/nri2326.
- Background: PubMed 17360651Hamanishi J, Mandai M, Iwasaki M, Okazaki T, Tanaka Y, Yamaguchi K, Higuchi T, Yagi H, Takakura K, Minato N, Honjo T, Fujii S. Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer. Proc Natl Acad Sci U S A. 2007 Feb 27;104(9):3360-5. doi: 10.1073/pnas.0611533104. Epub 2007 Feb 21.
- Background: PubMed 20143437Hino R, Kabashima K, Kato Y, Yagi H, Nakamura M, Honjo T, Okazaki T, Tokura Y. Tumor cell expression of programmed cell death-1 ligand 1 is a prognostic factor for malignant melanoma. Cancer. 2010 Apr 1;116(7):1757-66. doi: 10.1002/cncr.24899.
- Background: PubMed 15837746Ohigashi Y, Sho M, Yamada Y, Tsurui Y, Hamada K, Ikeda N, Mizuno T, Yoriki R, Kashizuka H, Yane K, Tsushima F, Otsuki N, Yagita H, Azuma M, Nakajima Y. Clinical significance of programmed death-1 ligand-1 and programmed death-1 ligand-2 expression in human esophageal cancer. Clin Cancer Res. 2005 Apr 15;11(8):2947-53. doi: 10.1158/1078-0432.CCR-04-1469.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyong Hwa Park, MD, PhD principal investigator
Korean Cancer Study Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with DDR Gene Mutation and Metastatic Solid Tumor, run by Korean Cancer Study Group at 2 sites in South Korea.
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 15 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyong Hwa Park, MD, PhD (+821047617651, khpark@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: within maximum 3 years). 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 NCT04761744, which also lists 33 linked publications.
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 21 Feb 2021.