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NeoplasmsPhase 1NCT01688206

A Study of Vanucizumab (RO5520985) Alone or in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase 1 study testing Atezolizumab [TECENTRIQ] and Vanucizumab in people with Neoplasms, run by Hoffmann-La Roche at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination with atezolizumab in participants with locally advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Atezolizumab [TECENTRIQ] and Vanucizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
14 sitesin 3 countries
Study dates
31 Oct 2012to 12 Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer
  • Participants must have platinum resistant disease defined as progression within <6 months from completion of a minimum of 4 platinum therapy cycles OR Participants must have platinum refractory disease, which is defined as progression during platinum based chemotherapy
  • Less than or equal to (<=) 2 prior lines of systemic therapy
  • The participant is willing to consent to and undergo a pre-treatment and on treatment core or excisional biopsy of the tumor
  • Measurable disease as determined by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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  • Adequate hematological function
  • Adequate liver function
  • Adequate renal function
  • Adequate coagulation
  • Adequate cardiovascular function
  • Recovery from all reversible adverse events of previous anti-cancer therapies to baseline or Common Terminology Criteria for Adverse Events (CTCAE) Grade (G) 1, except for alopecia (any grade) and <= G 2 sensory peripheral neuropathy

Who cannot join

  • Participants with primary central nervous system (CNS) tumors or CNS tumor involvement. Participants with metastatic CNS tumors may participate in this trial under conditions defined by protocol
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to Day 1 of Cycle 1 or anticipation of the need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure
  • Significant cardiovascular/cerebrovascular disease within 6 months prior to study drug administration
  • Known human immuno deficiency virus (HIV) infection or known active hepatitis B or hepatitis C virus infection or active tuberculosis
  • Participants previously treated with vascular endothelial growth factor (VEGF)-A inhibitors and with agents targeting Angiopoietin (Ang)-1/2 and/or Tyrosine-protein kinase receptor2
  • History of intra-abdominal inflammatory process within the last 12 months such as, but not limited to, diverticulitis, peptic ulcer disease, or colitis
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  • Any prior radiotherapy to the pelvis or abdomen
  • Treatment with systemic immunostimulatory agents, including but not limited to, interferon (IFN)-alpha, IFN-beta, interleukin (IL)-2, conjugated IL-2 cytokines within 6 weeks or five half-lives of the drug, whichever is longer, prior to screening
  • History of bowel obstruction and/or clinical signs or symptoms of gastro-intestinal obstruction, including sub-occlusive disease related to the underlying disease (however, participants with signs/symptoms of sub/occlusive syndrome/bowel obstruction at the time of initial diagnosis may be enrolled if they had received definitive [surgical] treatment for symptom resolution). History of abdominal fistula or tracheo-oesophageal fistula, gastrointestinal perforation or intra-abdominal abscess, unless occurred and resolved before initial diagnosis and unrelated to the underlying cancer disease. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on Computed tomography (CT)
  • Chronic daily treatment with non-steroidal anti-inflammatory drug (NSAID) (occasional use for the symptomatic relief of medical conditions, for example, headache, fever is allowed)
  • Treatment with systemic immunosuppressive medications including, but not limited, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to study drug administration
  • Previous treatment with checkpoint inhibitors (e.g. anti Programmed death [PD]-1, anti-PD-ligand 1, anti Cytotoxic T-lymphocyte-associated molecule-4) or prior treatment with cluster of differentiation (CD) 137 agonists or any other antibody or drug targeting T cell co-stimulation or other immune checkpoint blockade therapies
  • History of autoimmune disease including, but not limited to systemic lupus erythematosus (SLE), Sjögren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, systemic immune activation, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Guillain-Barré syndrome, Bell's palsy
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle1 Day1 or anticipation that such a live attenuated vaccine will be required during the study

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

France6 sites

  • Institut Bergonie; Oncologie

    Bordeaux, 33076

  • Centre Francois Baclesse; Oncologie

    Caen, 14076

  • Centre Leon Berard; Departement Oncologie Medicale

    Lyon, 69373

  • Institut Curie; Oncologie Medicale

    Paris, 75231

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

  • Institut Gustave Roussy; Sitep

    Villejuif, 94805

Other trials in France

Spain6 sites

  • Hospital del Mar; Servicio de Oncologia

    Barcelona, 08003

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

    Madrid, 28050

  • Clinica Universitaria de Navarra; Servicio de Oncologia

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

Other trials in Spain

Belgium2 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

About this study

Official title: An Open-label, Multi-center, Dose Escalation Phase I Study of Single Agent RO5520985 (Vanucizumab), and in Combination With Atezolizumab, Administered as an Intravenous Infusion in Patients With Locally Advanced or Metastatic Solid Tumors

This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD and/or recommended phase two dose [RP2D]), and fixed dose of vanucizumab in combination with atezolizumab, intravenously every 2 weeks.

Conditions
Neoplasms
Being tested
Atezolizumab [TECENTRIQ], Vanucizumab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab [TECENTRIQ]Biological

    Also called RO5541267

    Participants will receive atezolizumab at a fixed dose of 840 mg, intravenously every 2 weeks.

  • VanucizumabBiological

    Also called RO5520985

    Participants will receive escalating doses of vanucizumab (starting dose: 3 milligram [mg] per kilogram) and fixed dose of vanucizumab (MTD/RP2D: 30 mg/kg), intravenously every 2 weeks.

Study groups in NCT01688206
Study groupRoleWhat they receive
VanucizumabExperimentalParticipants will receive escalating doses of vanucizumab and fixed dose of vanucizumab, intravenously every 2 weeks.
Receives: Biological: Vanucizumab
Vanucizumab + AtezolizumabExperimentalParticipants will receive fixed dose of vanucizumab along with atezolizumab, intravenously every 2 weeks.
Receives: Biological: Atezolizumab [TECENTRIQ]; Biological: Vanucizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of Vanucizumab

    Measured: approximately 28 days

  2. Number of Participants With Objective Response According to RECIST 1.1 Criteria

    Measured: approximately 3 years

  3. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: approximately 3 years

  4. Number of Participants With Dose-limiting Toxicities (DLTs)

    Measured: approximately 28 days

Secondary outcomes (21)

  1. Elimination Half-life (t1/2) of Vanucizumab

    Measured: Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose)

  2. Area Under the Plasma Concentration-time Curve During one Dosing Interval (AUCtau) of Vanucizumab

    Measured: Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose)

  3. Clearance of Study Drug From the Body (CL)

    Measured: Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose)

  4. Volume of Distribution at Steady-State (Vss) of Vanucizumab

    Measured: Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose)

  5. Accumulation Ratio (RA) of Vanucizumab

    Measured: Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose)

  6. Number of Participants With Objective Response According to RECIST 1.1 Criteria, CA-125 Response Criteria, and Immune-modified RECIST Criteria

    Measured: approximately 3 years

  7. Number of Participants With Disease Control According to RECIST 1.1 Criteria

    Measured: approximately 3 years

  8. Progression Free Survival (PFS) According to RECIST 1.1 Criteria

    Measured: Baseline until disease progression or death (up to approximately 3 years)

  9. Biological Progression-free Interval (PFIbio) According to RECIST 1.1 Criteria

    Measured: Baseline until biologic progression or death (up to approximately 3 years)

  10. Overall Survival (OS)

    Measured: Baseline until death (up to approximately 3 years)

  11. Change From Baseline in Micro Vessel Density (MVD) Assessed by Paired Tumor Biopsies

    Measured: approximately 2 years

  12. Change From Baseline in Proliferation and Apoptosis of Endothelial cells and Tumor Cells Assessed by Paired Tumor Biopsies

    Measured: approximately 2 years

  13. Change From Baseline in Maturity of Blood Vessels Assessed by Paired Tumor Biopsies

    Measured: approximately 2 years

  14. Change From Baseline in Targets and Receptors Assessed by Paired Tumor Biopsies

    Measured: approximately 2 years

  15. Change From Baseline in Blood Plasma Volume (Vp), Extracellular Extravascular Space Volume (Ve), and Volume Transfer Coefficient, Assessed by Bio-Imaging

    Measured: approximately 2 years

  16. Change From Baseline in Apparent Diffusion Coefficient (ADC) Assessed by Bio-Imaging

    Measured: approximately 2 years

  17. Percentage of Participants With Human Anti-Human Antibodies (HAHA) to Vanucizumab and Atezolizumab (ATA)

    Measured: 0 hours (pre-dose) in Part I, II, and III (Cycle 1, 5, 6, end of study [EoS] visit) Part IV (Cycle 1, 3, 4, 8, every 8 weeks after cycle 8, EoS visit)

  18. Area under the Concentration-time Curve (AUC) of Vanucizumab

    Measured: Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose)

  19. Maximum Observed Plasma Concentration (Cmax) of Vanucizumab

    Measured: Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose)

  20. Minimum Observed Plasma Concentration (Cmin) of Vanucizumab

    Measured: Cycle 1 & 4: 0 hour (pre-dose); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose)

  21. Time of Observed Maximum Plasma Concentration (Tmax)

    Measured: Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2012 (estimated)
  2. Study start31 Oct 2012
  3. Primary completion2 Dec 2016
  4. Study completion12 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01688206
Sponsor's protocol ID
BP28179
Other IDs
2011-005877-22, RG7221
Status last verified
Oct 2018
First submitted
13 Sep 2012
Last updated
5 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab [TECENTRIQ] and Vanucizumab in people with Neoplasms, run by Hoffmann-La Roche at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of Vanucizumab (time frame: approximately 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01688206.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.

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