Clareo Health | Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors
Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Part I: Histologically confirmed advanced/metastatic solid tumor (except prostate cancer and squamous non-small cell lung cancer \[NSCLC\])
Part II: Histologically confirmed advanced/metastatic platinum-resistant ovarian carcinoma (aPROC), head and neck squamous cell carcinoma (HNSCC), or non-squamous NSCLC previously treated with anti-PD-L1/PD-1 inhibitor alone or in combination (e.g. atezolizumab, nivolumab, pembrolizumab, durvalumab, avelumab)
Checkpoint inhibitor (CPI)- experienced patients must have experienced documented disease progression on or after PD-L1/PD-1 inhibitor therapy
In CPI-experienced patients, the PD-L1/PD-1 inhibitor must have been part of the most recent systemic anticancer therapy administered prior to study enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Life expectancy \>/= 16 weeks
Adequate hematologic, renal, hepatic, and cardiovascular function
Measurable disease per Response Evaluation Criteria in Solid Tumors, v 1.1 (RECIST v1.1)
Tumors must be acceptable for biopsy. Participants in Part II may be enrolled without a biopsy if the collection is not clinically feasible.
Agreement to use adequate contraceptive measures among men or among women of childbearing potential
You may not be if
Prostate cancer or squamous NSCLC
Recent systemic anti-cancer treatment
Prior treatment with anti-programmed death (PD) 1 or anti-programmed death ligand (PD-L) 1 therapeutic antibody, vanucizumab, or compounds targeting cluster of differentiation (CD) 40 less than 4 weeks or 5xt1/2 (whichever is shorter) prior to enrollment
Part II: Treatment targeting vascular endothelial growth factor (VEGF) or receptor within 12 months prior to enrollment
Systemic immunosuppressive medication within 2 weeks prior to day 1 of cycle 1
Chronic daily treatment with non-steroidal anti-inflammatory drugs
Unacceptable/unresolved toxicity from prior anti-cancer therapy
Patients who have had a surgical procedure or significant traumatic injury within 28 days prior to initiation of study treatment, or a core biopsy or other minor surgical procedure within 7 days prior to initiation of study treatment
Bisphosphonate therapy for symptomatic hypercalcemia
Significant vascular disease
History of hypertensive crisis or hypertensive encephalopathy
Current or recent use of aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day)
History of vein thrombosis/thromboembolism, or use of anticoagulants within 7 days prior to study drug
Primary tumor in place in participants with colorectal cancer, or evidence of bowel involvement (metastasis, direct tumor invasion) in participants with other non-gastrointestinal cancer
Significant cardiovascular or cerebrovascular disease within 6 months prior to D1 of C1
History of fistula, bowel obstruction, perforation, or abscess
Prior radiotherapy to pelvis or abdomen, recto-sigmoid involvement, or bowel involvement among participants with aPROC
Severe non-healing wound, active ulcer or untreated bone fracture
Pregnant or lactating women
History of autoimmune disease
Human immunodeficiency virus (HIV) or hepatitis B or C
Severe infection or receipt of a live/attenuated vaccine within 4 weeks prior to D1 of C1
Other significant malignancies within 3 years prior to D1 of C1
Allergy/hypersensitivity to study drug
Prior allogeneic bone marrow or solid organ transplant
Other conditions/findings that may contraindicate use of study drug
Major surgery within 4 weeks prior to study drug
Known clinically significant liver disease
History of hemoptysis or bleeding diathesis, or known coagulopathies
Known symptomatic or untreated central nervous system (CNS) malignancy
