NIPH Clinical Trials Search

JRCT ID: jRCT2051210120

Registered date:09/11/2021

An investigator-initiated phase II trial of IMmune checkpoint inhibitor And niraparib for patients with homologous recombination repair GENE-mutated unresectable/recurrent advanced solid tumor

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUrothelial cancer, renal cancer, gastric cancer, esophageal cancer, head and neck cancer, melanoma
Date of first enrollment22/04/2022
Target sample size57
Countries of recruitment
Study typeInterventional
Intervention(s)Investigational drug Niraparib: 200 mg/body or 300 mg/body (body weight and neutrophil count greater than or equal to specified values), once daily Concomitant use of PD-1 inhibitors (Renal cancer, gastric cancer, esophageal cancer, head and neck cancer, malignant melanoma) Nivolumab: 240 mg/body, IV every 2 weeks (Urothelial cancer) Pembrolizumab: 240 mg/body, IV every 3 weeks. Continue administration unless protocol treatment discontinuation criteria are met.


Primary OutcomeObjective response rate (ORR) confirmed by site-investigator
Secondary Outcome1)Progression-free survival: PFS 2)Overall survival: OS 3)Disease control rate: DCR 4)Duration of response: DoR 5)Time to treatment failure: TTF 6)Changes of sum of tumor diameter 7)ORR in patients with HRR gene mutations on ctDNA testing 8)ORR, DCR, PFS and OS in patients with HRR gene mutation on ctDNA testing in each of germline and somatic cell mutations 9)Rate of adverse events

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria1) Malignant progression after one or more standard therapy by PD-1/PD-L1 inhibitors, and completion of standard therapy in principle 2) Diagnosed with the target disease (Unresectable advanced or recurrent urothelial cancer, renal cancer, gastric cancer, esophageal cancer, head and neck cancer, malignant melanoma) with HRR gene mutation in the germline or somatic cells which were detected by the specified tests 3) Measurable lesions 4) Participating in or planning to participate in MONSTAR-SCREEN-2 study 5) Legal adult on informed consent 6) ECOG PS: 0 or 1 7) Appropriate physical function confirmed by laboratory values within 14 days before enrollment 8) (Female of childbearing potential) Agreed to contraception and not to donate oocytes from the consent to 180 days after the last dose of Niraparib 9) (Male) Agreed to contraception from the start of study treatment to 180 days after the last dose of Niraparib, and agreed not to donate sperms from the start of study treatment to 90 days after the last dose of Niraparib or 120 days after the last dose of a PD-1 inhibitor, whichever is later. 10) Written consent to participate in the clinical trial
Exclude criteria1) Active double and more cancer 2) History of treatment with PARP inhibitors 3) Moderate or severe ascites observed by CT or MRI performed within 28 days prior to the enrollment 4) Diagnosed with carcinomatous meningitis, symptomatic brain metastases, or spinal metastases requiring surgical intervention at the enrollment, 5) Received systemic steroid therapy (10 mg/day or more dose equivalent to prednisolone) or immunosuppressants within 14 days before enrollment 6) Received any cytotoxic anticancer drugs, molecular-targeted drugs or antibodies for aimed at treating cancer within a certain period of time before enrollment 7) Performed surgery with systemic anesthesia within 21 days before enrollment, or unrecovered fully from the complications of the surgery 8) Performed radiation therapy within 14 days before enrollment, or requiring corticosteroids (10 mg/day or more dose equivalent to prednisolone) without recovery from radiation therapy-related toxicity 9) Historic or coexisting symptomatic congestive heart failure (NYHA Classes 2-4) within 6 months before enrollment, or arrhythmia requiring treatment 10) Historic or coexisting myocardial infarction or unstable angina within 6 months before enrollment 11) Uncontrolled hypertension at the enrollment 12) Lymphatic malignancy at the enrollment. 13) History of myelodysplastic syndrome or acute myeloid leukemia 14) History of bone marrow transplantation or organ transplantation 15) Historic or coexisting noninfectious interstitial lung disease or pneumonitis requiring steroid therapy at the enrollment 16) Active autoimmune disease requiring systemic therapy within 2 years before enrollment 17) Received live vaccines within 30 days before the scheduled start of protocol treatment 18) Infections requiring intravenous antibiotics, antivirals or antifungals at the enrollment 19) Active hepatitis B at the enrollment 20) Positive HIV antibody, HTLV -1 antibody or HCV antibody at the enrollment 21) Unrecovered adverse events to Grade 1 or less 22) Serious hypersensitivity to components of drugs used in protocol therapy identified at the enrollment 23) Rare genetic disorders of lactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption 24) (Female) Pregnant (including suspected pregnancy) or breastfeeding 25) Psychosis or psychiatric symptoms judged as difficult to participate in the study by the investigator 26) Permanently discontinuation of PD-1/PD-L1 inhibitors in the prior therapy due to immune-mediated adverse events

Related Information


Public contact
Name Hiroshi Miyamoto
Address Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka Osaka Japan 530-0044
Telephone +81-6-6358-7110
Affiliation FiveRings Co.,Ltd.
Scientific contact
Name Taigo Kato
Address 2-15 Yamadaoka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-5111
Affiliation Osaka University Hospital