Advanced MalignanciesPhase 1NCT02520245
Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study
A Phase 1 study testing REGN2810 in people with Advanced Malignancies, run by Regeneron Pharmaceuticals at 9 sites in United States.
Trial summary
This study has been designed to collect long-term follow-up information for patients who received REGN2810 in other clinical studies and to allow re-treatment for eligible patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- REGN2810
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2015to Nov 2023
- 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
- Tolerated prior treatment with REGN2810 with no unacceptable toxicity (except select reversible irAEs) requiring discontinuation of REGN2810
- Developed documented progressive disease after first demonstrating clinical benefit from their initial treatment
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- ≥18 years old
- Hepatic function:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN; if liver metastases ≤ 3 x ULN)
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- Transaminases ≤ 3 x ULN (or ≤ 5.0 x ULN, if liver metastases)
- Alkaline phosphatase (ALP) ≤ 2.5 x ULN (or ≤ 5.0 x ULN, if liver metastases)
- For patients with hepatic metastases or hepatic malignancies, exclude patients with concomitant 3 x ULN ≤ aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 5 x ULN and 1.5 x ULN ≤ total bilirubin ≤ 3 x ULN
- Renal function: Serum creatinine ≤ 1.5 x ULN
- Bone marrow function:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelet count ≥ 75 x 10^9/L
- Inclusion Criteria for Patients who Will not Receive Re-treatment:
- Patients must have completed participation in any REGN2810 clinical study.
Who cannot join
- A patient who meets any of the following criteria will be excluded from receiving re-treatment with REGN2810:
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
- Patients who experienced an irAE in while participating in another REGN2810 protocol who were unable to have their corticosteroid dose reduced to <10 mg per day prednisone equivalent within 12 weeks of toxicity.
- Patients who developed ≥ Grade 2 uveitis in a prior REGN2810 protocol
- Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
- Active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus.
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- History of pneumonitis within the last 5 years.
- Any investigational or antitumor treatment within 30 days prior to the initial administration of REGN2810.
- History of documented allergic reactions or acute hypersensitivity reaction attributed of Grade ≥ 3 severity during or directly following an REGN2810 infusion
- Known allergy to doxycycline or tetracycline. (precaution due to presence of trace components in REGN2810)
- Breast-feeding
- Positive serum pregnancy test
- History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- Acute or chronic psychiatric problems that, under the evaluation of the investigator, make the patient ineligible for participation
- Unwilling to practice adequate contraception during the study until 6 months after the last dose of study drug
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University Hospitals Case Medical Center
Cleveland, Ohio
Sarah Cannon Research Institute at HealthONE
Denver, Colorado
City of Hope National Medical Center
Duarte, California
Sarah Cannon Research Institute
Nashville, Tennessee
Laura & Isaac Perlmutter Cancer Center
New York, New York
Stephenson Cancer Center
Oklahoma City, Oklahoma
Providence Portland Medical Center
Portland, Oregon
START South Texas Accelerated Research Therapeutics
San Antonio, Texas
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri
About this study
This study has been designed to collect long-term follow-up information for patients who received REGN2810 in other clinical studies and to allow re-treatment for eligible patients.
- Conditions
- Advanced Malignancies
- Being tested
- REGN2810
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN2810Drug
Patients will receive REGN2810 by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Open-Label | Experimental | Not described Receives: Drug: REGN2810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring
Measured: up to 8 years
Safety measured by the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome.
Safety includes the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome.
Measured: up to 8 years
Secondary outcomes (2)
Response duration (time from best overall response of partial or complete response, to time to first documented disease progression)
Measured: up to 8 years
Duration of disease control (time from best overall response of SD as well as PR and CR to time to first do documented disease progression)
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520245
- Sponsor's protocol ID
- R2810-ONC-1425
- Status last verified
- May 2016
- First submitted
- 5 Aug 2015
- Last updated
- 7 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study
- ClinicalTrials.gov ID
- NCT02520245
- Acronym / sponsor ID
- R2810-ONC-1425
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 11 Aug 2015 (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 study has been designed to collect long-term follow-up information for patients who received REGN2810 in other clinical studies and to allow re-treatment for eligible patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label | Experimental | Drug: REGN2810 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Tolerated prior treatment with REGN2810 with no unacceptable toxicity (except select reversible irAEs) requiring discontinuation of REGN2810
- Developed documented progressive disease after first demonstrating clinical benefit from their initial treatment
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- ≥18 years old
- Hepatic function:
Key exclusion criteria (15 listed)
- A patient who meets any of the following criteria will be excluded from receiving re-treatment with REGN2810:
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
- Patients who experienced an irAE in while participating in another REGN2810 protocol who were unable to have their corticosteroid dose reduced to <10 mg per day prednisone equivalent within 12 weeks of toxicity.
- Patients who developed ≥ Grade 2 uveitis in a prior REGN2810 protocol
- Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
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 |
|---|---|---|
| REGN2810Patients will receive REGN2810 by intravenous (IV) infusion | Drug | Open-Label |
Primary outcome
Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring
Time frame: up to 8 years
Safety measured by the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome.
Time frame: up to 8 years
Safety includes the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome.
2 secondary outcomes
Response duration (time from best overall response of partial or complete response, to time to first documented disease progression)
Time frame: up to 8 years
Duration of disease control (time from best overall response of SD as well as PR and CR to time to first do documented disease progression)
Time frame: up to 8 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
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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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN2810 in people with Advanced Malignancies, run by Regeneron Pharmaceuticals at 9 sites in United States.
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 16 inclusion and 15 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: withdrawn, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring (time frame: up to 8 years). The study lists 2 primary outcomes in all. 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 7 Nov 2016.