Advanced CancerPhase 1NCT02383212
Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies
A Phase 1 study testing Cemiplimab, Hypofractionated radiotherapy and Cyclophosphamide in people with Advanced Cancer and Advanced Malignancies, run by Regeneron Pharmaceuticals at 47 sites in 3 countries.
Trial summary
This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Advanced Malignancies
- What is being tested?
- Cemiplimab, Hypofractionated radiotherapy and Cyclophosphamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 47 sitesin 3 countries
- Study dates
- 2 Feb 2015to 18 Nov 2019
- 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
- Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply).
- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment (certain exceptions may apply)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
- Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)
- Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.
- Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of progression by imaging for at least 6 weeks prior to the first dose of study treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of cemiplimab (certain exceptions may apply).
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab
- The information provided above is not intended to contain all considerations relevant to potential participation in a clinical trial, therefore not all inclusion/ exclusion criteria are listed.
Trial locations and contacts
47 sites in 3 countries.
47 sites in 3 countries
United States40 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia
Dana Farber Cancer Institute
Boston, Massachusetts
University of Chicago
Chicago, Illinois
University Hospitals Case Medical Center
Cleveland, Ohio
Mary Crowley Cancer Research Center - Medical City
Dallas, Texas
Sarah Cannon Research Institute at HealthONE
Denver, Colorado
Barbara Ann Karmanos Cancer Center
Detroit, Michigan
City of Hope National Medical Center
Duarte, California
Duke Cancer Institute
Durham, North Carolina
University of Kansas Cancer Center
Fairway, Kansas
Banner MD Anderson Cancer Center
Gilbert, Arizona
Western Regional Medical Center
Goodyear, Arizona
Hackensack University Medical Center
Hackensack, New Jersey
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania
Baylor College of Medicine
Houston, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas
Indiana University
Indianapolis, Indiana
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Ronald Reagan UCLA Medical Center
Los Angeles, California
Sarah Cannon Research Institute
Nashville, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee
Cancer Institute of New Jersey
New Brunswick, New Jersey
Columbia University Medical Center
New York, New York
Laura & Isaac Perlmutter Cancer Center
New York, New York
Mount Sinai Medical Center
New York, New York
Weill Cornell Medical College
New York, New York
Norwalk Hospital
Norwalk, Connecticut
Stephenson Cancer Center
Oklahoma City, Oklahoma
Nebraska Methodist Hospital
Omaha, Nebraska
Mayo Clinic
Phoenix, Arizona
University of Pittsburgh Medical Center Shadyside
Pittsburgh, Pennsylvania, 15232
Providence Portland Medical Center
Portland, Oregon
Miriam Hospital
Providence, Rhode Island
START South Texas Accelerated Research Therapeutics
San Antonio, Texas
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri
Stanford University
Stanford, California
Northwest Medical Specialties
Tacoma, Washington
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida
University of Arizona Cancer Center
Tucson, Arizona
Georgetown University Medical Center
Washington D.C., District of Columbia
Spain6 sites
Hospital Universitario Vall d'Hebron
Barcelona
Institut Catala d'Oncologia L'hospitalet
L'Hospitalet de Llobregat, Barcelona
Fundacion Jimenez Diaz
Madrid
Hospital Universitario HM Sanchinarro-CIOCC
Madrid
Hospital Universitario Ramon y Cajal
Madrid
MD Anderson Cancer Center
Madrid
About this study
Official title: A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD-1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies
This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.
- Conditions
- Advanced Cancer, Advanced Malignancies
- Being tested
- Cemiplimab, Hypofractionated radiotherapy, Cyclophosphamide, Docetaxel, Carboplatin
- Keywords
- Advanced cancerous growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called REGN2810, Libtayo
Hypofractionated radiotherapyRadiation
CyclophosphamideDrug
DocetaxelDrug
CarboplatinDrug
GM-CSFDrug
Also called LEUKINE®
PaclitaxelDrug
PemetrexedDrug
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Cohort | Experimental | Cemiplimab will be administered alone Receives: Drug: Cemiplimab |
| Dual Combination Cohorts | Experimental | Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy
Doses of cemiplimab will be administered in combination with Cyclophosphamide
Doses of cemiplimab will be administered in combination with Docetaxel Receives: Drug: Cemiplimab; Radiation: Hypofractionated radiotherapy; Drug: Cyclophosphamide; Drug: Docetaxel |
| Triple Combination Cohorts | Experimental | Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus Cyclophosphamide
Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF
Doses of cemiplimab will be administered in combination with Carboplatin plus Paclitaxel
Doses of cemiplimab will be administered in combination with Carboplatin plus Pemetrexed
Doses of cemiplimab will be administered in combination with Carboplatin plus Docetaxel Receives: Drug: Cemiplimab; Radiation: Hypofractionated radiotherapy; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Carboplatin; Drug: GM-CSF; Drug: Paclitaxel; Drug: Pemetrexed |
| Quadruple Combination Cohorts | Experimental | Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide Receives: Drug: Cemiplimab; Radiation: Hypofractionated radiotherapy; Drug: Cyclophosphamide; Drug: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Primary safety variables include incidence and severity of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs)
Measured: Change from baseline to week 48
Incidence of abnormal laboratory findings
Measured: Change from baseline to week 48
Number of participants with dose limiting toxicities (DLTs)
Measured: Change from baseline to 28 days after first dose of cemiplimab
Secondary outcomes (5)
Response Evaluation Criteria in Solid Tumors (RECIST) as measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to week 48
Immune-Related Response Criteria (irRC) applied to RECIST measurements
Measured: Change from baseline to week 48
Incidence of development of anti-cemiplimab antibodies
Measured: Up to week 48
Antitumor activity measured by progression-free survival (PFS)
Measured: Up to 72 weeks
Antitumor activity measured by overall survival
Measured: Up to 249 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start2 Feb 2015
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 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
- NCT02383212
- Sponsor's protocol ID
- R2810-ONC-1423
- Other IDs
- 2015-002132-41, 2015
- Status last verified
- Jan 2020
- First submitted
- 2 Feb 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Babiker H, Brana I, Mahadevan D, Owonikoko T, Calvo E, Rischin D, Moreno V, Papadopoulos KP, Crittenden M, Formenti S, Giralt J, Garrido P, Soria A, Hervas-Moron A, Mohan KK, Fury M, Lowy I, Mathias M, Feng M, Li J, Stankevich E. Phase I Trial of Cemiplimab, Radiotherapy, Cyclophosphamide, and Granulocyte Macrophage Colony-Stimulating Factor in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Oncologist. 2021 Sep;26(9):e1508-e1513. doi: 10.1002/onco.13810. Epub 2021 May 22.
PubMed 33942954Moreno V, Garrido P, Papadopoulos KP, De Miguel Luken MJ, Gil-Martin M, Aljumaily R, Rosen LS, Rietschel P, Mohan KK, Yoo SY, Stankevich E, Lowy I, Fury MG. Tolerability and antitumor activity of cemiplimab, a human monoclonal anti-PD-1, as monotherapy in patients with pretreated non-small cell lung cancer (NSCLC): Data from the Phase 1 NSCLC expansion cohort. Lung Cancer. 2021 May;155:151-155. doi: 10.1016/j.lungcan.2021.02.034. Epub 2021 Mar 4.
PubMed 33831732Rischin D, Migden MR, Lim AM, Schmults CD, Khushalani NI, Hughes BGM, Schadendorf D, Dunn LA, Hernandez-Aya L, Chang ALS, Modi B, Hauschild A, Ulrich C, Eigentler T, Stein B, Pavlick AC, Geiger JL, Gutzmer R, Alam M, Okoye E, Mathias M, Jankovic V, Stankevich E, Booth J, Li S, Lowy I, Fury MG, Guminski A. Phase 2 study of cemiplimab in patients with metastatic cutaneous squamous cell carcinoma: primary analysis of fixed-dosing, long-term outcome of weight-based dosing. J Immunother Cancer. 2020 Jun;8(1):e000775. doi: 10.1136/jitc-2020-000775.
PubMed 32554615Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
PubMed 29863979Falchook GS, Leidner R, Stankevich E, Piening B, Bifulco C, Lowy I, Fury MG. Responses of metastatic basal cell and cutaneous squamous cell carcinomas to anti-PD1 monoclonal antibody REGN2810. J Immunother Cancer. 2016 Nov 15;4:70. doi: 10.1186/s40425-016-0176-3. eCollection 2016.
PubMed 27879972
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD-1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02383212
- Acronym / sponsor ID
- R2810-ONC-1423
- Conditions
- Advanced Cancer, Advanced Malignancies
- Keywords
- Advanced cancerous growth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 9 Mar 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 is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Cohort | Experimental | Drug: CemiplimabCemiplimab will be administered alone |
| Dual Combination Cohorts | Experimental | Drug: Cemiplimab, Radiation: Hypofractionated radiotherapy, Drug: Cyclophosphamide, Drug: DocetaxelDoses of cemiplimab will be administered in combination with hypofractionated radiotherapy Doses of cemiplimab will be administered in combination with Cyclophosphamide Doses of cemiplimab will be administered in combination with Docetaxel |
| Triple Combination Cohorts | Experimental | Drug: Cemiplimab, Radiation: Hypofractionated radiotherapy, Drug: Cyclophosphamide, Drug: Docetaxel, Drug: Carboplatin, Drug: GM-CSF, Drug: Paclitaxel, Drug: PemetrexedDoses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus Cyclophosphamide Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF Doses of cemiplimab will be administered in combination with Carboplatin plus Paclitaxel Doses of cemiplimab will be administered in combination with Carboplatin plus Pemetrexed Doses of cemiplimab will be administered in combination with Carboplatin plus Docetaxel |
| Quadruple Combination Cohorts | Experimental | Drug: Cemiplimab, Radiation: Hypofractionated radiotherapy, Drug: Cyclophosphamide, Drug: GM-CSFDoses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply).
- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment (certain exceptions may apply)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (6 listed)
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
- Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)
- Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.
- Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of progression by imaging for at least 6 weeks prior to the first dose of study treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of cemiplimab (certain exceptions may apply).
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab
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 |
|---|---|---|
| CemiplimabAlso: REGN2810, Libtayo | Drug | Dual Combination Cohorts, Monotherapy Cohort, Quadruple Combination Cohorts, Triple Combination Cohorts |
| Hypofractionated radiotherapy | Radiation | Dual Combination Cohorts, Quadruple Combination Cohorts, Triple Combination Cohorts |
| Cyclophosphamide | Drug | Dual Combination Cohorts, Quadruple Combination Cohorts, Triple Combination Cohorts |
| Docetaxel | Drug | Dual Combination Cohorts, Triple Combination Cohorts |
| Carboplatin | Drug | Triple Combination Cohorts |
| GM-CSFAlso: LEUKINE® | Drug | Quadruple Combination Cohorts, Triple Combination Cohorts |
| Paclitaxel | Drug | Triple Combination Cohorts |
| Pemetrexed | Drug | Triple Combination Cohorts |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Change from baseline to week 48
Primary safety variables include incidence and severity of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs)
Incidence of abnormal laboratory findings
Time frame: Change from baseline to week 48
Number of participants with dose limiting toxicities (DLTs)
Time frame: Change from baseline to 28 days after first dose of cemiplimab
5 secondary outcomes
Response Evaluation Criteria in Solid Tumors (RECIST) as measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Time frame: Change from baseline to week 48
Immune-Related Response Criteria (irRC) applied to RECIST measurements
Time frame: Change from baseline to week 48
Incidence of development of anti-cemiplimab antibodies
Time frame: Up to week 48
Antitumor activity measured by progression-free survival (PFS)
Time frame: Up to 72 weeks
Antitumor activity measured by overall survival
Time frame: Up to 249 weeks
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 27 Jan 2020.
- Derived from this study: PubMed 33942954Babiker H, Brana I, Mahadevan D, Owonikoko T, Calvo E, Rischin D, Moreno V, Papadopoulos KP, Crittenden M, Formenti S, Giralt J, Garrido P, Soria A, Hervas-Moron A, Mohan KK, Fury M, Lowy I, Mathias M, Feng M, Li J, Stankevich E. Phase I Trial of Cemiplimab, Radiotherapy, Cyclophosphamide, and Granulocyte Macrophage Colony-Stimulating Factor in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Oncologist. 2021 Sep;26(9):e1508-e1513. doi: 10.1002/onco.13810. Epub 2021 May 22.
- Derived from this study: PubMed 33831732Moreno V, Garrido P, Papadopoulos KP, De Miguel Luken MJ, Gil-Martin M, Aljumaily R, Rosen LS, Rietschel P, Mohan KK, Yoo SY, Stankevich E, Lowy I, Fury MG. Tolerability and antitumor activity of cemiplimab, a human monoclonal anti-PD-1, as monotherapy in patients with pretreated non-small cell lung cancer (NSCLC): Data from the Phase 1 NSCLC expansion cohort. Lung Cancer. 2021 May;155:151-155. doi: 10.1016/j.lungcan.2021.02.034. Epub 2021 Mar 4.
- Derived from this study: PubMed 32554615Rischin D, Migden MR, Lim AM, Schmults CD, Khushalani NI, Hughes BGM, Schadendorf D, Dunn LA, Hernandez-Aya L, Chang ALS, Modi B, Hauschild A, Ulrich C, Eigentler T, Stein B, Pavlick AC, Geiger JL, Gutzmer R, Alam M, Okoye E, Mathias M, Jankovic V, Stankevich E, Booth J, Li S, Lowy I, Fury MG, Guminski A. Phase 2 study of cemiplimab in patients with metastatic cutaneous squamous cell carcinoma: primary analysis of fixed-dosing, long-term outcome of weight-based dosing. J Immunother Cancer. 2020 Jun;8(1):e000775. doi: 10.1136/jitc-2020-000775.
- Derived from this study: PubMed 29863979Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
- Derived from this study: PubMed 27879972Falchook GS, Leidner R, Stankevich E, Piening B, Bifulco C, Lowy I, Fury MG. Responses of metastatic basal cell and cutaneous squamous cell carcinomas to anti-PD1 monoclonal antibody REGN2810. J Immunother Cancer. 2016 Nov 15;4:70. doi: 10.1186/s40425-016-0176-3. eCollection 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
47 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cemiplimab, Hypofractionated radiotherapy and Cyclophosphamide in people with Advanced Cancer and Advanced Malignancies, run by Regeneron Pharmaceuticals at 47 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 3 inclusion and 6 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Spain, Australia. 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?
Incidence of Treatment Emergent Adverse Events (TEAEs) (time frame: Change from baseline to week 48). The study lists 3 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 NCT02383212, which also lists 5 linked publications.
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 27 Jan 2020.