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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02665416
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Solid Tumors Drug: Selicrelumab Drug: Vanucizumab Drug: Bevacizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 25, 2016
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Part I (Dose Escalation): Selicrelumab, Vanucizumab
Participants will receive a fixed dose of vanucizumab, 2 grams via IV infusion on Days 1 and 15 of every 28-day cycle. Selicrelumab will be given SC, or potentially IV, in ascending dose levels on Day 2 of Cycles 1 to 4 and every third cycle thereafter. Treatment will continue as long as the participant experiences clinical benefit or until unacceptable toxicity, withdrawal of consent, or the end of Part I of the study (expected 9 months).
Drug: Selicrelumab
Selicrelumab will be provided as concentrate for solution to be administered via SC injection or IV infusion.
Other Name: RO7009789

Drug: Vanucizumab
Vanucizumab will be provided as solution to be administered via IV infusion.

Experimental: Part II (Expansion): Selicrelumab, Bevacizumab
Bevacizumab will be administered via IV infusion on days 1 and 15 of every 28-day cycle. Selicrelumab will be given SC after the Bevacizumab infusion at the dose determined in the Part I of the study on Day 2 of Cycles 1 to 4 and every third cycle thereafter. Treatment will continue as long as the participant experiences clinical benefit or until unacceptable toxicity, withdrawal of consent, or the end of Part II of the study (expected 15 months).
Drug: Selicrelumab
Selicrelumab will be provided as concentrate for solution to be administered via SC injection or IV infusion.
Other Name: RO7009789

Drug: Bevacizumab
Bevacizumab will be administered via IV infusion.




Primary Outcome Measures :
  1. Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: From Day (D) 1 until D28 of Cycle (C)1 ]
  2. MTD of Selicrelumab in Combination With Vanucizumab [ Time Frame: From D1 until D28 of C1 ]
  3. Recommended Phase II Dose of Selicrelumab in Combination With Vanucizumab [ Time Frame: From D1 until D28 of C1 ]
  4. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From D1 of C1 until treatment discontinuation and approximately 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  5. Clinical Activity of SC Selicrelumab in Combination with Bevacizumab as Assessed by Response Evaluation in Solid Tumors, Version 1.1 (RECIST v1.1) [ Time Frame: From D1 of C1 through safety follow up visit (45 days post final dose; Cycle = 28 days) ]
  6. Clinical Activity of SC Selicrelumab in Combination with Bevacizumab as Assessed by Unidimensional Immune-Related Response Criteria (irRC) [ Time Frame: From D1 of C1 through safety follow up visit (45 days post final dose; Cycle = 28 days) ]

Secondary Outcome Measures :
  1. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Selicrelumab [ Time Frame: Predose (-1 hour [h]) on D2 of C1, C2, C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  2. Percentage of Participants with ADAs to Vanucizumab [ Time Frame: Predose (within 10 minutes [min] before infusion) on D1 of C1, C2, C4, and every 2 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  3. Area Under the Concentration-Time Curve From Time 0 to Last Measureable Concentration (AUClast) of Selicrelumab Following Subcutaneous (SC) Administration [ Time Frame: Predose (-1 h) and 3 (only C2), 4, 8, 24, 48, 72 h postdose on C1 and C2; predose (-1 h) and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II) ]
    Each cycle will be 28 days in duration.

  4. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Selicrelumab Following SC Administration [ Time Frame: Predose (-1 h) and 3 (only C2), 4, 8, 24, 48, 72 h postdose on C1 and C2; predose (-1 h) and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II) ]
    Each cycle will be 28 days in duration.

  5. Maximum Concentration (Cmax) of Selicrelumab Following SC Administration [ Time Frame: Predose (-1 h) and 3 (only C2), 4, 8, 24, 48, 72 h postdose on C1 and C2; predose (-1 h) and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II) ]
    Each cycle will be 28 days in duration.

  6. Time to Maximum Concentration (Tmax) of Selicrelumab Following SC Administration [ Time Frame: Predose (-1 h) and 3 (only C2), 4, 8, 24, 48, 72 h postdose on C1 and C2; predose (-1 h) and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II) ]
    Each cycle will be 28 days in duration.

  7. Apparent Clearance (CL/F) of Selicrelumab Following SC Administration [ Time Frame: Predose (-1 h) and 3 (only C2), 4, 8, 24, 48, 72 h postdose on C1 and C2; predose (-1 h) and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II) ]
    Each cycle will be 28 days in duration.

  8. Apparent Volume of Distribution (Vd/F) of Selicrelumab Following SC Administration [ Time Frame: Predose (-1 h) and 3 (only C2), 4, 8, 24, 48, 72 h postdose on C1 and C2; predose (-1 h) and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II) ]
    Each cycle will be 28 days in duration.

  9. Apparent Terminal Half-Life (t1/2) of Selicrelumab Following SC Administration [ Time Frame: Predose (-1 h) and 3 (only C2), 4, 8, 24, 48, 72 h postdose on C1 and C2; predose (-1 h) and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II) ]
    Each cycle will be 28 days in duration.

  10. AUClast of Selicrelumab Following Intravenous (IV) Administration [ Time Frame: D2 of C1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (-1 h) and 15 min, at the end of infusion (infusion duration=30 min), 2, 4, 6, 8, 10, 24, 30-36, 48, 72, 168 h postdose on C1 and C2; predose (-1 h), at the end of infusion, and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days)

  11. AUCinf of Selicrelumab Following IV Administration [ Time Frame: D2 of C1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (-1 h) and 15 min, at the end of infusion (infusion duration=30 min), 2, 4, 6, 8, 10, 24, 30-36, 48, 72, 168 h postdose on C1 and C2; predose (-1 h), at the end of infusion, and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days)

  12. Cmax of Selicrelumab Following IV Administration [ Time Frame: D2 of C1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (-1 h) and 15 min, at the end of infusion (infusion duration=30 min), 2, 4, 6, 8, 10, 24, 30-36, 48, 72, 168 h postdose on C1 and C2; predose (-1 h), at the end of infusion, and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days)

  13. Minimum Concentration (Cmin) of Selicrelumab Following IV Administration [ Time Frame: D2 of C1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (-1 h) and 15 min, at the end of infusion (infusion duration=30 min), 2, 4, 6, 8, 10, 24, 30-36, 48, 72, 168 h postdose on C1 and C2; predose (-1 h), at the end of infusion, and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days)

  14. CL of Selicrelumab Following IV Administration [ Time Frame: D2 of C1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (-1 h) and 15 min, at the end of infusion (infusion duration=30 min), 2, 4, 6, 8, 10, 24, 30-36, 48, 72, 168 h postdose on C1 and C2; predose (-1 h), at the end of infusion, and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days)

  15. Volume of Distribution at Steady-State (Vss) of Selicrelumab Following IV Administration [ Time Frame: D2 of C1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (-1 h) and 15 min, at the end of infusion (infusion duration=30 min), 2, 4, 6, 8, 10, 24, 30-36, 48, 72, 168 h postdose on C1 and C2; predose (-1 h), at the end of infusion, and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days)

  16. t1/2 of Selicrelumab Following IV Administration [ Time Frame: D2 of C1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (-1 h) and 15 min, at the end of infusion (infusion duration=30 min), 2, 4, 6, 8, 10, 24, 30-36, 48, 72, 168 h postdose on C1 and C2; predose (-1 h), at the end of infusion, and 8 h postdose on C3, C4, C7, and every 3 cycles until/at disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days)

  17. AUClast of Vanucizumab [ Time Frame: Day 1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (within 10 min) on D1 of C1, C2, C4, C6, C8, every 2 cycles thereafter disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days); predose (within 10 min), end of infusion (infusion duration=60-90 min) on D15 of C1 to C9 and each cycle thereafter until disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II); 6 and 24 h postdose on D15 of C1

  18. AUCinf of Vanucizumab [ Time Frame: Day 1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (within 10 min) on D1 of C1, C2, C4, C6, C8, every 2 cycles thereafter disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days); predose (within 10 min), end of infusion (infusion duration=60-90 min) on D15 of C1 to C9 and each cycle thereafter until disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II); 6 and 24 h postdose on D15 of C1

  19. Concentration at the End of Infusion (Cend) of Vanucizumab [ Time Frame: Day 1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (within 10 min) on D1 of C1, C2, C4, C6, C8, every 2 cycles thereafter disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days); predose (within 10 min), end of infusion (infusion duration=60-90 min) on D15 of C1 to C9 and each cycle thereafter until disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II); 6 and 24 h postdose on D15 of C1

  20. CL of Vanucizumab [ Time Frame: Day 1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (within 10 min) on D1 of C1, C2, C4, C6, C8, every 2 cycles thereafter disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days); predose (within 10 min), end of infusion (infusion duration=60-90 min) on D15 of C1 to C9 and each cycle thereafter until disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II); 6 and 24 h postdose on D15 of C1

  21. Vss of Vanucizumab [ Time Frame: Day 1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (within 10 min) on D1 of C1, C2, C4, C6, C8, every 2 cycles thereafter disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days); predose (within 10 min), end of infusion (infusion duration=60-90 min) on D15 of C1 to C9 and each cycle thereafter until disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II); 6 and 24 h postdose on D15 of C1

  22. t1/2 of Vanucizumab [ Time Frame: Day 1 up to 9 months in Part I and 15 months in Part II (detailed timeframe is provided in outcome description) ]
    Predose (within 10 min) on D1 of C1, C2, C4, C6, C8, every 2 cycles thereafter disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days); predose (within 10 min), end of infusion (infusion duration=60-90 min) on D15 of C1 to C9 and each cycle thereafter until disease progression and/or 45 days after last dose (up to 9 months in Part I and 15 months in Part II); 6 and 24 h postdose on D15 of C1

  23. Change in Blood and Tumor Tissue Immune Cell Subpopulations [ Time Frame: From D1 of C1 until D9 of C10 or disease progression, whichever occurs first (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  24. Change in Peripheral Blood Level of Cytokines [ Time Frame: From D1 of C1 to 3 h postdose on D2 of C4 or disease progression, whichever occurs first (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  25. Change in Blood Soluble Proteins [ Time Frame: From D1 of C1 until D15 of C7 or disease progression, whichever occurs first (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  26. Percentage of Participants With Best Overall Response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria [ Time Frame: Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  27. Percentage of Participants With Best overall Response Immune-Related Response Criteria (irRC) [ Time Frame: Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  28. Duration of Objective Response per RECIST v1.1 Criteria [ Time Frame: Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  29. Duration of Objective Response per irRC [ Time Frame: Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  30. Percentage of Participants With Disease Control per RECIST v1.1 Criteria [ Time Frame: Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  31. Percentage of Participants With Disease Control per irRC [ Time Frame: Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  32. Progression-free Survival (PFS) per RECIST v1.1 Criteria [ Time Frame: Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  33. PFS per irRC [ Time Frame: Tumor assessments at Screening and on D1 of C3, C5, C7; and every 12 weeks thereafter until disease progression (up to 9 months in Part I and 15 months in Part II; cycle length=28 days) ]
  34. Overall Survival (OS) [ Time Frame: Baseline until death (up to 9 months in Part I and 15 months in Part II) ]
  35. Concentration at the end of Infusion (Cend) of Bevacizumab [ Time Frame: D1 and D15 of C1, then D1 of every cycle until C7; at radiographical disease progression/tumor regression; at safety follow up visit (45 days post final dose; Cycle = 28 days) ]
  36. Minimum Concentration (Cmin) of Bevacizumab after Infusion [ Time Frame: D1 and D15 of C1, then D1 of every cycle until C7; at radiographical disease progression/tumor regression; at safety follow up visit (45 days post final dose; Cycle = 28 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665416


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Colorado
Univ of CO Health Science Ctr
Denver, Colorado, United States, 80262
United States, Connecticut
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Belgium
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
Canada, Ontario
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Denmark
Rigshospitalet; Onkologisk Klinik
København Ø, Denmark, 2100
Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milano, Lombardia, Italy, 20132
Netherlands
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Spain
ICO L'Hospitalet; Servicio de oncologia medica
L Hospitalet De Llobregat, Barcelona, Spain, 08908
Hospital del Mar; Servicio de Oncologia
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02665416    
Other Study ID Numbers: BP29889
2015-003480-11 ( EudraCT Number )
RG7876 ( Other Identifier: Roche )
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors