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NCT02383212 · CITED IN SOURCE DOCUMENTS

Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2020-01-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Key Inclusion Criteria: 1. 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). 2. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment (certain exceptions may apply) 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Key Exclusion Criteria: 1. 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. 2. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply) 3. 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. 4. 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). 5. 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Cemiplimab will be administered alone
    intervention Names
    1. Drug: Cemiplimab
    label
    Monotherapy Cohort
    type
    EXPERIMENTAL
  2. description
    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
    intervention Names
    1. Drug: Cemiplimab
    2. Radiation: Hypofractionated radiotherapy
    3. Drug: Cyclophosphamide
    4. Drug: Docetaxel
    label
    Dual Combination Cohorts
    type
    EXPERIMENTAL
  3. description
    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
    intervention Names
    1. Drug: Cemiplimab
    2. Radiation: Hypofractionated radiotherapy
    3. Drug: Cyclophosphamide
    4. Drug: Docetaxel
    5. Drug: Carboplatin
    6. Drug: GM-CSF
    7. Drug: Paclitaxel
    8. Drug: Pemetrexed
    label
    Triple Combination Cohorts
    type
    EXPERIMENTAL
  4. description
    Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide
    intervention Names
    1. Drug: Cemiplimab
    2. Radiation: Hypofractionated radiotherapy
    3. Drug: Cyclophosphamide
    4. Drug: GM-CSF
    label
    Quadruple Combination Cohorts
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dual Combination Cohorts
    2. Monotherapy Cohort
    3. Quadruple Combination Cohorts
    4. Triple Combination Cohorts
    name
    Cemiplimab
    other Names
    1. REGN2810
    2. Libtayo
    type
    DRUG
  2. arm Group Labels
    1. Dual Combination Cohorts
    2. Quadruple Combination Cohorts
    3. Triple Combination Cohorts
    name
    Hypofractionated radiotherapy
    type
    RADIATION
  3. arm Group Labels
    1. Dual Combination Cohorts
    2. Quadruple Combination Cohorts
    3. Triple Combination Cohorts
    name
    Cyclophosphamide
    type
    DRUG
  4. arm Group Labels
    1. Dual Combination Cohorts
    2. Triple Combination Cohorts
    name
    Docetaxel
    type
    DRUG
  5. arm Group Labels
    1. Triple Combination Cohorts
    name
    Carboplatin
    type
    DRUG
  6. arm Group Labels
    1. Quadruple Combination Cohorts
    2. Triple Combination Cohorts
    name
    GM-CSF
    other Names
    1. LEUKINE®
    type
    DRUG
  7. arm Group Labels
    1. Triple Combination Cohorts
    name
    Paclitaxel
    type
    DRUG
  8. arm Group Labels
    1. Triple Combination Cohorts
    name
    Pemetrexed
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
398
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Primary safety variables include incidence and severity of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs)
    measure
    Incidence of Treatment Emergent Adverse Events (TEAEs)
    time Frame
    Change from baseline to week 48
  2. measure
    Incidence of abnormal laboratory findings
    time Frame
    Change from baseline to week 48
  3. measure
    Number of participants with dose limiting toxicities (DLTs)
    time Frame
    Change from baseline to 28 days after first dose of cemiplimab
secondary Outcomes
  1. measure
    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
  2. measure
    Immune-Related Response Criteria (irRC) applied to RECIST measurements
    time Frame
    Change from baseline to week 48
  3. measure
    Incidence of development of anti-cemiplimab antibodies
    time Frame
    Up to week 48
  4. measure
    Antitumor activity measured by progression-free survival (PFS)
    time Frame
    Up to 72 weeks
  5. measure
    Antitumor activity measured by overall survival
    time Frame
    Up to 249 weeks
Full study description
brief 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.
Source references
references
  1. citation
    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.
    pmid
    33942954
    type
    DERIVED
  2. citation
    Moreno 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.
    pmid
    33831732
    type
    DERIVED
  3. citation
    Rischin 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.
    pmid
    32554615
    type
    DERIVED
  4. citation
    Migden 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.
    pmid
    29863979
    type
    DERIVED
  5. citation
    Falchook 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.
    pmid
    27879972
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        " tabindex="-1">Evidence (cemiplimab):</p> <div class="pdq-content-list"><ol id="_590"><li>A phase I expansion cohort trial (<a href="/clinicaltrials/NCT02383212">NCT02383212</a>) that required patients to have at least one measurable lesion enrolled patients with metastatic (n = 16) or locally advanced (n = 10) SCC. C
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        1">Evidence (cemiplimab):</p> <div class="pdq-content-list"><ol id="_590"><li>A phase I expansion cohort trial (<a href="/clinicaltrials/NCT02383212">NCT02383212</a>) that required patients to have at least one measurable lesion enrolled patients with metastatic (n = 16) or locally advanced (n = 10) SCC. Cemiplimab was
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      1. context
        Updated: May 12, 2025
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        May 12, 2025

    Preserved source evidence · Not medical advice