Solid TumorsPhase 1NCT01688960
Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies
A Phase 1 study testing nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept) in people with Solid Tumors, run by Regeneron Pharmaceuticals at 6 sites in 2 countries.
Trial summary
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2012to Nov 2014
- 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
- Inclusion criteria include, but are not limited to, the following:
- Confirmed diagnosis of solid tumor malignancy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hepatic, renal and bone marrow function
- Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1
Who cannot join
- Exclusion criteria include, but are not limited to, the following:
- Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
- Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg
- Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
- Patients with deep vein thrombosis or pulmonary embolism within last 3 months
- Patients with serious non healing wound or acute ulcer
Show all 11Show fewer
- Patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months
- Patients with history of abdominal or tracheal-esophageal fistula
- Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors
- Prior treatment with bevacizumab within last 6 weeks
- Pregnant or breast-feeding women
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Study site
Indianapolis, Indiana
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Philadelphia, Pennsylvania
Study site
San Antonio, Texas
About this study
Official title: A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)
- Conditions
- Solid Tumors
- Being tested
- nesvacumab (REGN910/ SAR307746), aflibercept (ziv-aflibercept)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nesvacumab (REGN910/ SAR307746)Drug
Dose level 1
nesvacumab (REGN910/ SAR307746)Drug
Dose level 2
nesvacumab (REGN910/ SAR307746)Drug
Dose level 3
aflibercept (ziv-aflibercept)Drug
Also called In US: aflibercept is known as ziv-aflibercept
Dose level 1
aflibercept (ziv-aflibercept)Drug
Also called In US: aflibercept is known as ziv-aflibercept
Dose level 2
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: nesvacumab (REGN910/ SAR307746); Drug: aflibercept (ziv-aflibercept) |
| Cohort 2 | Experimental | Not described Receives: Drug: nesvacumab (REGN910/ SAR307746); Drug: aflibercept (ziv-aflibercept) |
| Cohort 3a | Experimental | Not described Receives: Drug: nesvacumab (REGN910/ SAR307746); Drug: aflibercept (ziv-aflibercept) |
| Cohort 3b | Experimental | Not described Receives: Drug: nesvacumab (REGN910/ SAR307746); Drug: aflibercept (ziv-aflibercept) |
| Cohort 4 | Experimental | Not described Receives: Drug: nesvacumab (REGN910/ SAR307746); Drug: aflibercept (ziv-aflibercept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) administered in combination with aflibercept (ziv-aflibercept) in patients with advanced solid malignancies
Measured: Day 1 to Day 28
Secondary outcomes (4)
Pharmacokinetics (PK)
To assess PK parameters such as concentration of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept).
Measured: Day 1 to Day 170
Immunogenicity
To assess the anti-drug antibodies of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept)
Measured: Day 1 to Day 170
Antitumor activity
Objective tumor response according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1
Measured: Day 1 to Day 170
Pharmacodynamics (PD)
Target inhibition biomarker changes, serum tumor markers
Measured: Day 1 to Day 170
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688960
- Sponsor's protocol ID
- R910-ST-1114
- Status last verified
- Mar 2015
- First submitted
- 17 Sep 2012
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01688960
- Acronym / sponsor ID
- R910-ST-1114
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: nesvacumab (REGN910/ SAR307746), Drug: aflibercept (ziv-aflibercept) |
| Cohort 2 | Experimental | Drug: nesvacumab (REGN910/ SAR307746), Drug: aflibercept (ziv-aflibercept) |
| Cohort 3a | Experimental | Drug: nesvacumab (REGN910/ SAR307746), Drug: aflibercept (ziv-aflibercept) |
| Cohort 3b | Experimental | Drug: nesvacumab (REGN910/ SAR307746), Drug: aflibercept (ziv-aflibercept) |
| Cohort 4 | Experimental | Drug: nesvacumab (REGN910/ SAR307746), Drug: aflibercept (ziv-aflibercept) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of solid tumor malignancy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hepatic, renal and bone marrow function
- Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1
Key exclusion criteria (11 listed)
- Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
- Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg
- Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
- Patients with deep vein thrombosis or pulmonary embolism within last 3 months
- Patients with serious non healing wound or acute ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nesvacumab (REGN910/ SAR307746)Dose level 1 | Drug | Cohort 1 |
| nesvacumab (REGN910/ SAR307746)Dose level 2 | Drug | Cohort 2, Cohort 3b |
| nesvacumab (REGN910/ SAR307746)Dose level 3 | Drug | Cohort 3a, Cohort 4 |
| aflibercept (ziv-aflibercept)Also: In US: aflibercept is known as ziv-afliberceptDose level 1 | Drug | Cohort 1, Cohort 2, Cohort 3a |
| aflibercept (ziv-aflibercept)Also: In US: aflibercept is known as ziv-afliberceptDose level 2 | Drug | Cohort 3b, Cohort 4 |
Primary outcome
Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Time frame: Day 1 to Day 28
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) administered in combination with aflibercept (ziv-aflibercept) in patients with advanced solid malignancies
4 secondary outcomes
Pharmacokinetics (PK)
Time frame: Day 1 to Day 170
Immunogenicity
Time frame: Day 1 to Day 170
Antitumor activity
Time frame: Day 1 to Day 170
Pharmacodynamics (PD)
Time frame: Day 1 to Day 170
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept) in people with Solid Tumors, run by Regeneron Pharmaceuticals at 6 sites in 2 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 5 inclusion and 11 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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 Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015.