A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors

JRCT ID: jRCT2031200408

Registered date:10/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Solid Tumors
• Date of first enrollment: 02/03/2021
• Target sample size: 200
• Countries of recruitment: USA,Japan,Belgium,Japan,France,Japan,Italy,Japan,Korea,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Drug: Regorafenib, (Stivarga, BAY73-4506)

Intake orally, starting with 3x 30 mg tablets every day (once daily.) for 21 days of every 28-day cycle (21 days on, 7 days off).

If the starting dose is well tolerated dose can be escalated to 120 mg (4x30 mg tablets).

Drug: Nivolumab (Opdivo)
480 mg administered on Day 1 of each treatment cycle.

Outcome(s)

• Primary Outcome: Overall response rate (ORR) [ Time Frame: Up to the last participant having been followed for approximately 10 months, summing up to approximately 2.5 years ]

Secondary Outcome

1.Duration of response (DOR) [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]

2.Disease control rate (DCR) [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]

3.Progression free survival (PFS) [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]

4.6 months PFS [ Time Frame: 6 months ]

5.Overall survival (OS) [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]

6.1 year OS [ Time Frame: 1 year ]

7.Severity of AEs (adverse events) per CTCAE v 5.0 [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]
CTCAE: Common terminology criteria for adverse events

8.Number of participants with adverse events [ Time Frame: From first dosing up to the end of the study (LPLV), summing up to approximately 4 years ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Histologically confirmed selected recurrent or metastatic solid tumor types that have progressed after treatment with standard therapies and for which there are no curative intent surgery or chemoradiation.
- Cohort 1: subjects with HNSCC (Head and neck squamous-cell carcinoma) who have progressed on or after prior systemic therapy have not received prior PD-1/PD-L1 inhibitor therapy.
- Cohort 2: subjects with HNSCC who have progressed on or after prior systemic therapy, at least one of which included a PD-1/PD-L1 inhibitor alone or in combination with chemotherapy.
- Cohort 3: subjects with ESCC (Esophageal Squamous Cell Carcinoma) who progressed on or after platinum and/or fluoropyrimidine based regimen.
- Cohort 4: subjects with PDAC (Pancreatic ductal adenocarcinoma) who have progressed on or after gemcitabine or fluoropyrimidine based regimens.
- Cohort 5: subjects with BTC (Biliary tract carcinoma) (intrahepatic or extrahepatic cholangiocarcinoma or gall bladder cancer) who have progressed on gemcitabine or fluoropyrimidine or platinum therapy or a combination of these agents.
- Cohort 6: subjects with Grade IV GBM (Glioblastoma multiforme) or Grade III AA (Anaplastic astrocytoma) (World Health Organization [WHO] criteria) with unequivocal first progression after surgery followed by radiotherapy and temozolomide.

Exclude criteria

- Presence of symptomatic central nervous system (CNS) metastases, leptomeningeal metastases or spinal cord compression. Previously-treated lesions should be stable for at least 6 weeks prior to study entry.
- Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment.
- Prior therapy with PD-1/PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or any form of immunotherapy to treat cancer (except cohort 2).
- Cohort 2: More than one prior therapy with PD-1/PD-L1 or CTLA-4 inhibitors, or any other form of immunotherapy to treat cancer.
- ESCC:
patients with apparent tumor invasion on organs located adjacent to the esophageal disease (e.g., the aorta or respiratory tract).
patients who have previously received taxane agents for recurrent/metastatic cancer.
- GBM/AA
Primary tumors localized to the brainstem or spinal cord.
Presence of diffuse leptomeningeal disease or extracranial disease.
Participants requiring > 4 mg of dexamethasone or biologic equivalent per day to control symptoms related to brain tumor and cerebral edema within 21 days of starting study treatment.

Related Information

• Primary Sponsor: Tanigawa Takahiko
• Secondary Sponsor: Bristol-Myers Squibb,ONO PHARMACEUTICAL CO.,LTD.
• Secondary ID(s): NCT04704154