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8095 Innovation Park Drive, Fairfax, VA 22031


Open-label, randomized Phase II trial with BNT111 and cemiplimab in combination or as single agents in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV melanoma (BioNTech 111-01)


General Information

Age Group




Protocol Number


Background Information

The research study involves the development and testing of investigational drugs called BNT111 and cemiplimab, when used alone or in combination. The main goals of this study are to test whether BNT111 alone or in combination with cemiplimab are more effective at reducing disease and increasing survival outcomes compared to cemiplimab alone; and to see if BNT111 alone or in combination with cemiplimab are as safe and well tolerated as cemiplimab alone.

BNT111 has not been approved by the FDA and is considered investigational. Cemiplimab has been approved by the FDA for treatment of squamous cell carcinoma but not melanoma. Therefore the use of Cemiplimab either alone or in combination with BNT111 in this study is also considered investigational.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital

Eligibility Information

  • Participants must be aged ≥18 years on the date of signing the informed consent
  • Participants must have histologically confirmed unresectable Stage III or IV (metastatic) cutaneous melanoma and measurable disease by RECIST 1.1
  • Participants must have confirmed disease progression on/after approved anti-PD1 regimen for melanoma as defined by RECIST 1.1:
    1. Previous exposure to approved anti-PD1 containing regimen for at least 12 consecutive weeks and
    2. Radiological progression to be confirmed by 2 scans 4-12 weeks apart. If progression is accompanied by new symptoms, or deterioration of performance status not attributed to toxicity, one scan is sufficient
    3. Progression must be while on treatment with approved anti-PD1 regimen for melanoma or within 6 months of discontinuing anti-PD1 treatment, and regardless of any intervening therapy
  • Participants should have received pembrolizumab or nivolumab (with/without ipilimumab)
  • Participants should have received at least 1 but no more than 5 lines of prior therapy for advanced disease
  • Participants must be able to tolerate additional anti-PD1 therapy (i.e., did not permanently discontinue anti-PD1 therapy due to toxicity)
  • Participants must have known BRAF mutation status
  • Participants with BRAF V600-positive tumor(s) should have received prior treatment with a BRAF inhibitor (alone or in combination with a MEK inhibitor) in addition to treatment with pembrolizumab or nivolumab with or without ipilimumab Note: Participants with BRAF V600-positive tumors with no clinically significant tumor-related symptoms or evidence of rapidly progressive disease are not required to be treated with a BRAF inhibitor (alone or in combination with a MEK inhibitor) based on investigator’s decision
  • Adequate bone marrow function as defined by hematological parameters:
    • Participant should have adequate hepatic function
    • Participant should have adequate kidney function, assessed by the estimated glomerular filtration rate (eGFR) ≥30 mL/min using the CKD-EPI equation
    • Participant should be stable with adequate coagulation
  • Additional eligibility in protocol

Ineligibility Information

  • Participants must not be pregnant or breastfeeding
  • Participants must not have history of uveal, acral, or mucosal melanoma
  • Participants must have no ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related adverse events (irAEs). Note: Participants with autoimmune-related hyperthyroidism, autoimmune-related hypothyroidism who are in remission, or on a stable dose of thyroid-replacement hormone, vitiligo, or psoriasis may be included
  • Participants must have no known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T cell-negative severe combined immunodeficiency [SCID]) or combined T and B cell immunodeficiencies (e.g., T and –B negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency)
  • Participants with uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency are not eligible
  • Participants must have no uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed
    • Participants with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For participants with controlled HIV infection, monitoring will be performed per local standards
    • Participants with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Participants with controlled infections must undergo periodic monitoring of HBV DNA per local standards. Participants must remain on anti-viral therapy for at least 6 months beyond the last dose of trial treatment
    • Participants who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted
    • Participants with HIV or hepatitis must have their disease reviewed by the specialist (e.g., infectious disease specialist or hepatologist) managing this disease prior to commencing and throughout the duration of their participation in the trial
    • Participants with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis, progression or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, non-invasive, superficial bladder cancer or breast ductal carcinoma in situ)
  • Systemic immune suppression:
    • Use of chronic systemic steroid medication (up to 5 mg/day prednisolone equivalent is allowed); participants using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible,
    • Other clinically relevant systemic immune suppression
  • Treatment with other anti-cancer therapy including chemotherapy, radiotherapy, investigational, or biological cancer therapy within 3 weeks prior to the first dose of trial treatment (6 weeks for nitrosureas). Adjuvant hormonotherapy used for breast cancer in long term remission (refer to Exclusion criterion #7) is allowed
  • Participants who have had a splenectomy
  • Current evidence of new or growing brain or spinal metastases during screening. Participants with leptomeningeal disease are excluded. Participants with known brain or spinal metastases may be eligible if they:
    • Had radiotherapy or another appropriate therapy for the brain or spinal bone metastases,
    • Have no neurological symptoms that can be attributed to the current brain lesions,
    • Have stable brain or spinal disease on the CT or MRI scan within 4 weeks before signing the informed consent (confirmed by stable lesions on two scans at least 4 weeks apart),
    • Do not require steroid therapy within 14 days before the first dose of trial treatment,
    • Spinal bone metastases are allowed, unless imminent fracture or cord compression is anticipated
  • History or current evidence of significant cardiovascular disease
  • Additional ineligibility in protocol

Additional information can be found at: NCT04526899