Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:January 25, 2016
End Date:June 9, 2020
Contact:Reference Study ID Number: BP29889 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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An Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Cohorts to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of RO7009789 (CD40 Agonistic Monoclonal Antibody) in Combination With Vanucizumab (Anti-Ang2 and Anti-VEGF Bi-Specific Monoclonal Antibody, Part I) or Bevacizumab (Anti-VEGF Monoclonal Antibody, Part II) in Patients With Metastatic Solid Tumors

This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic
activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with
metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is
designed to establish the maximum tolerated dose (MTD) of Selicrelumab in this combination.
Part II (expansion) is intended to characterize the safety and tolerability of Selicrelumab
in combination with bevacizumab among indication-specific cohorts and to confirm the
recommended dose.


Inclusion Criteria:

- 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

- Agreement to use adequate contraceptive measures among men or among women of
childbearing potential

Exclusion Criteria:

- 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

- 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 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
We found this trial at
6
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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10 Avenue Hippocrate
Bruxelles, 1200
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Bruxelles,
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Denver, Colorado 80262
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Denver, CO
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333 Cedar Street
New Haven, Connecticut 06520
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New Haven, CT
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