A study to test different doses of BI 836880 combined with ezabenlimab in patients with advanced non-small cell lung cancer followed by other types of advanced solid tumours
- Conditions
- advanced solid tumours
- Registration Number
- JPRN-jRCT2031200207
- Lead Sponsor
- Yamagami Tomohiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
1.Of full age (according to local legislation, usually >= 18 years) at screening
2.At least one measurable target lesion outside the brain (excluding the glioblastoma patients), that can be accurately measured per RECIST v 1.1
3.ECOG performance status <= 1 (Karnofsky status for GBM)
4.Adequate hepatic, renal and bone marrow functions
5.Availability and willingness to provide a fresh tumor tissue sample obtained after relapse or progression on or after prior therapy. In case a fresh biopsy cannot be obtained (e.g. inaccessible lesions or patient safety concern), an archived specimen obtained up to 6 months prior to cycle 1, visit 1 (C1V1) may be submitted in case no systemic antineoplastic therapy has been administered between the biopsy and C1V1 (except for cohort D). For cohorts E, F and G, a fresh on-treatment biopsy is mandatory at C3D1, if possible from the same lesion as the pre-treatment biopsy.
6.Life expectancy >= 3 months after start of the treatment in the opinion of the investigator
1.Not more than one CPI based treatment regimen prior to entering study (eg. anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody) unless combination CPIs approved by the local regulatory agencies; For eg., Melanoma cohort (Cohort E)
2.Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (exception for patients in HCC cohorts; Cohort F & cohort G).
3.Prior treatment with any antiangiogenic treatment (e.g. bevacizumab, cediranib, aflibercept, vandetanib, XL-184, sunitinib, etc) except for sorafenib and lenvatinib in 2nd line HCC cohort (Cohort F).
4.Patients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening
Further exclusion criteria:
Exclusion criteria for Glioblastoma:
5.Tumor primarily localized to the brainstem or spinal cord.
6.Presence of diffuse leptomeningeal disease or extracranial disease.
7.Is known to have IDH mutant variety of recurrent glioblastoma.
8.Any prior treatment with prolifeprospan 20 with carmustine wafer.
9.Any prior treatment with an intracerebral agent.
Exclusion criteria for Melanoma cohort:
10.Uveal or ocular melanoma
Exclusion criteria for HCC cohorts (Cohorts F & G):
11.Co-infection with HBV and HCV or HBV and hepatitis D virus (HDV)
12. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
13.History of hepatic encephalopathy
14.Untreated or incompletely treated varices with bleeding or high-risk for bleeding
15. Untreated active Hepatitis B virus (HBV)
16. Treatment with any HCV anti-viral therapy within 4 weeks prior to Cycle 1 Day 1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the shrinkage estimator of objective response(OR) based on BHM
- Secondary Outcome Measures
Name Time Method