Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04526899




Registration number
NCT04526899
Ethics application status
Date submitted
18/08/2020
Date registered
26/08/2020
Date last updated
6/03/2024

Titles & IDs
Public title
Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
Scientific title
Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
Secondary ID [1] 0 0
2020-002195-12
Secondary ID [2] 0 0
BNT111-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma Stage III 0 0
Melanoma Stage IV 0 0
Unresectable Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BNT111
Other interventions - Cemiplimab

Experimental: BNT111 + cemiplimab -

Experimental: BNT111 monotherapy -

Experimental: Cemiplimab monotherapy -


Other interventions: BNT111
IV injection

Other interventions: Cemiplimab
IV infusion
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) - Arm: BNT111 + cemiplimab
Timepoint [1] 0 0
up to 24 months
Secondary outcome [1] 0 0
Objective response rate - Arm: BNT111 monotherapy and Arm: Cemiplimab monotherapy
Timepoint [1] 0 0
up to 24 months
Secondary outcome [2] 0 0
Duration of response (DOR) according to RECIST 1.1
Timepoint [2] 0 0
up to 24 months
Secondary outcome [3] 0 0
Disease control rate (DCR) according to RECIST 1.1
Timepoint [3] 0 0
up to 24 months
Secondary outcome [4] 0 0
Time to response (TTR) according to RECIST 1.1
Timepoint [4] 0 0
up to 24 months
Secondary outcome [5] 0 0
Progression-free survival (PFS) according to RECIST 1.1
Timepoint [5] 0 0
up to 24 months
Secondary outcome [6] 0 0
ORR according to RECIST 1.1 as assessed by the investigator
Timepoint [6] 0 0
up to 24 months
Secondary outcome [7] 0 0
DOR according to RECIST 1.1 as assessed by the investigator
Timepoint [7] 0 0
up to 24 months
Secondary outcome [8] 0 0
DCR according to RECIST 1.1 as assessed by the investigator
Timepoint [8] 0 0
up to 24 months
Secondary outcome [9] 0 0
TTR according to RECIST 1.1 as assessed by the investigator
Timepoint [9] 0 0
up to 24 months
Secondary outcome [10] 0 0
PFS according to RECIST 1.1 as assessed by the investigator
Timepoint [10] 0 0
up to 24 months
Secondary outcome [11] 0 0
Overall survival (OS) - Arm: BNT111 + cemiplimab
Timepoint [11] 0 0
up to 48 months
Secondary outcome [12] 0 0
Occurrence of treatment-emergent adverse events (TEAE) within a patient including Grade =3, serious and/or fatal TEAE by relationship
Timepoint [12] 0 0
up to 27 months
Secondary outcome [13] 0 0
Occurrence of immune-related adverse events (irAE)
Timepoint [13] 0 0
up to 27 months
Secondary outcome [14] 0 0
Occurrence of dose reduction and discontinuation of trial treatment within a patient due to TEAE
Timepoint [14] 0 0
up to 27 months
Secondary outcome [15] 0 0
Occurrence of abnormal laboratory parameters (hematology) within a patient
Timepoint [15] 0 0
up to 25 months
Secondary outcome [16] 0 0
Changes in laboratory parameters (hematology) compared to baseline
Timepoint [16] 0 0
up to 25 months
Secondary outcome [17] 0 0
Occurrence of abnormal laboratory parameters (clinical chemistry) within a patient
Timepoint [17] 0 0
up to 25 months
Secondary outcome [18] 0 0
Changes in laboratory parameters (clinical chemistry) compared to baseline
Timepoint [18] 0 0
up to 25 months
Secondary outcome [19] 0 0
Occurrence of abnormal laboratory parameters (coagulation factors) within a patient
Timepoint [19] 0 0
up to 25 months
Secondary outcome [20] 0 0
Changes in laboratory parameters (coagulation factors) compared to baseline
Timepoint [20] 0 0
up to 25 months
Secondary outcome [21] 0 0
Occurrence of abnormal laboratory parameters (endocrine tests) within a patient
Timepoint [21] 0 0
up to 25 months
Secondary outcome [22] 0 0
Changes in laboratory parameters (endocrine tests) compared to baseline
Timepoint [22] 0 0
up to 25 months
Secondary outcome [23] 0 0
Occurrence of abnormal laboratory parameters (serology) within a patient
Timepoint [23] 0 0
up to 25 months
Secondary outcome [24] 0 0
Changes in laboratory parameters (serology) compared to baseline
Timepoint [24] 0 0
up to 25 months
Secondary outcome [25] 0 0
Occurrence of abnormal laboratory parameters (urinalysis) within a patient
Timepoint [25] 0 0
up to 25 months
Secondary outcome [26] 0 0
Changes in laboratory parameters (urinalysis) compared to baseline
Timepoint [26] 0 0
up to 25 months
Secondary outcome [27] 0 0
Occurrence of abnormal vital signs parameters (body temperature) within a patient
Timepoint [27] 0 0
up to 25 months
Secondary outcome [28] 0 0
Changes in vital signs parameters (body temperature) compared to baseline
Timepoint [28] 0 0
up to 25 months
Secondary outcome [29] 0 0
Occurrence of abnormal vital signs parameters (pulse rate) within a patient
Timepoint [29] 0 0
up to 25 months
Secondary outcome [30] 0 0
Changes in vital signs parameters (pulse rate) compared to baseline
Timepoint [30] 0 0
up to 25 months
Secondary outcome [31] 0 0
Occurrence of abnormal vital signs parameters (blood pressure) within a patient
Timepoint [31] 0 0
up to 25 months
Secondary outcome [32] 0 0
Changes in vital signs parameters (blood pressure) compared to baseline
Timepoint [32] 0 0
up to 25 months
Secondary outcome [33] 0 0
Occurrence of abnormal vital signs parameters (respiratory rate) within a patient
Timepoint [33] 0 0
up to 25 months
Secondary outcome [34] 0 0
Changes in vital signs parameters (respiratory rate) compared to baseline
Timepoint [34] 0 0
up to 25 months
Secondary outcome [35] 0 0
Mean changes from baseline in the global health status score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30)
Timepoint [35] 0 0
up to 25 months
Secondary outcome [36] 0 0
Mean changes from baseline in scores of the EORTC QLQ C30 functional and symptoms scales
Timepoint [36] 0 0
up to 25 months
Secondary outcome [37] 0 0
Time to first clinically meaningful deterioration in global health status score as measured by EORTC QLQ-C30
Timepoint [37] 0 0
up to 25 months
Secondary outcome [38] 0 0
Time to first clinically meaningful deterioration in symptoms and functioning as measured by EORTC QLQ-C30
Timepoint [38] 0 0
up to 25 months

Eligibility
Key inclusion criteria
- Patients must sign the written informed consent form (ICF) before any screening
procedure.

- Patients must be aged = 18 years on the date of signing the informed consent.

- Patients must be willing and able to comply with scheduled visits, treatment schedule,
laboratory tests, and other requirements of the trial.

- Patients must have histologically confirmed unresectable Stage III or IV (metastatic)
cutaneous melanoma and measurable disease by RECIST 1.1.

- Patients must have confirmed disease progression on/after an approved anti-PD-1/PD-L1
regimen for melanoma as defined by RECIST 1.1.

1. Previous exposure to approved anti-PD-1/PD-L1 containing regimen for at least 12
consecutive weeks and

2. Current radiological progression to be confirmed by two scans 4 to 12 weeks
apart. If progression is accompanied by new symptoms, or deterioration of
performance status not attributed to toxicity, one scan is sufficient and

3. Inclusion into this trial must be within 6 months of confirmation of disease
progression on anti-PD-1/PD-L1 treatment, regardless of any intervening therapy.

- Patients should have received at least one but no more than five lines of prior
therapy for advanced disease.

- Patients must be able to tolerate additional anti-PD-1/PD-L1 therapy (i.e., did not
permanently discontinue anti-PD-1/PD-L1 therapy due to toxicity).

- Patients must have known B-Raf proto-oncogene (BRAF) mutation status.

- Patients with BRAF V600-positive tumor(s) should have received prior treatment with a
BRAF inhibitor (alone or in combination with a mitogen-activated protein kinase kinase
[MEK] inhibitor).

- Note: Considering the possible negative impact of a prior BRAF/MEK therapy on
immune system targeting therapies, patients with BRAF V600-positive tumors with
no clinically significant tumor-related symptoms or evidence of rapid PD may be
eligible for participation. This should be based on investigator assessment AND
provided they are ineligible for, intolerant to, or have refused BRAF V600
mutation targeted therapy after receiving the information on possible other
therapies including BRAF/MEK inhibitor-based therapy during the informed consent
process.

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status
(PS) = 1.

- Adequate bone marrow function, as defined by hematological parameters (as defined in
the protocol).

- Patients must have serum lactate dehydrogenase (LDH) = upper limit of normal (ULN).

- Patient should have adequate hepatic function, as defined in the protocol.

- Patient should have adequate kidney function, assessed by the estimated glomerular
filtration rate (eGFR) = 30 mL/min using the chronic kidney disease epidemiology
collaboration (CKD-EPI) equation.

- Patient should be stable with adequate coagulation, as defined in the protocol.

- Patients must provide the following biopsy samples:

1. All patients: must provide a tumor tissue sample (formalin fixed
paraffin-embedded [FFPE] blocks/slides) from a fresh biopsy collected before
Visit C1D1, or archival tissue. The archival tissue can be an FFPE block (not
older than 3 years) or freshly cut slides (special storage conditions and
immediate shipment to specialty lab are required), preferably derived from
advanced disease stage.

2. Patients at selected trial sites: After additional consent, patients must be
amenable to pre-treatment and on-treatment peripheral blood mononuclear cell
(PBMC) sampling and optional biopsy. If amenable, patients should provide a PBMC
sample and optionally a biopsy which contains tumor tissue after failure/stop of
last prior trial treatment.

- Women of childbearing potential (WOCBP) must have a negative serum (beta-human
chorionic gonadotropin [beta-hCG]) at screening. Patients that are postmenopausal or
permanently sterilized can be considered as not having reproductive potential. Female
patients of reproductive potential must agree to use highly effective contraception
during and for 6 months after the last trial drug administration.

- WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during trial starting at screening, during the trial and for 6 months
after receiving the last trial treatment.

- A man who is sexually active with a WOCBP and has not had a vasectomy must agree to
use a barrier method of birth control, e.g., either condom with spermicidal
foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men
must also not donate sperm during the trial and for 6 months after receiving the last
trial treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients must not be pregnant or breastfeeding.

- Patients must not have history of uveal, acral, or mucosal melanoma.

- Patients 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 pose a risk for irAEs.

- Note: Patients 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.

- Patients 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).

- Patients with uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal
insufficiency are not eligible.

- Patients 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.

1. Patients with known HIV who have controlled infection (undetectable viral load
and CD4 count above 350 either spontaneously or on a stable anti-viral regimen)
are permitted. For patients with controlled HIV infection, monitoring will be
performed per local standards.

2. Patients with known hepatitis B virus (HBV) who have controlled infection (serum
hepatitis B virus DNA polymerase chain reaction (PCR) that is below the limit of
detection AND receiving anti-viral therapy for hepatitis B) are permitted.
Patients with controlled infections must undergo periodic monitoring of HBV DNA
per local standards. Patients must remain on anti-viral therapy for at least 6
months beyond the last dose of trial treatment.

3. Patients who are known hepatitis C virus (HCV) antibody positive 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.

4. Patients 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.

- Patients 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).

- Current use or use within 3 months prior to trial enrollment of systemic immune
suppression including:

1. use of chronic systemic steroid medication (up to 5 mg/day prednisolone
equivalent is allowed); patients using physiological replacement doses of
prednisone for adrenal or pituitary insufficiency are eligible,

2. 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 is allowed.

- Current evidence of ongoing National Cancer Institute Common Terminology Criteria for
Adverse Events (NCI-CTCAE) v5.0 Grade > 1 toxicity of prior therapies before the start
of treatment, with the exception of hair loss, hearing loss, Grade 2 peripheral
neuropathy, or laboratory abnormalities not considered clinical significant per
investigator's discretion, and those Grade 2 toxicities listed as permitted in other
eligibility criteria.

- Patients who have a local infection (e.g., cellulitis, abscess) or systemic infection
(e. g., pneumonia, septicemia) which requires systemic antibiotic treatment within 2
weeks prior to the first dose of trial treatment.

- Patients who have had a splenectomy.

- Patients who have had major surgery (e.g., requiring general anesthesia) within 4
weeks before screening, have not fully recovered from surgery, or have a surgery
planned during the time of trial participation.

- Current evidence of new or growing brain or spinal metastases during screening.
Patients with leptomeningeal disease are excluded. Patients with known brain or spinal
metastases may be eligible if they:

1. had radiotherapy or another appropriate therapy for the brain or spinal bone
metastases,

2. have no neurological symptoms that can be attributed to the current brain
lesions,

3. have stable brain or spinal disease on the computed tomography (CT) or magnetic
resonance imaging (MRI) scan within 4 weeks before randomization (confirmed by
stable lesions on two scans at least 4 weeks apart, the second scan can be
carried out during screening),

4. do not require steroid therapy within 14 days before the first dose of trial
treatment,

5. spinal bone metastases are allowed, unless imminent fracture or cord compression
is anticipated.

- History or current evidence of significant cardiovascular disease including, but not
limited to:

1. angina pectoris requiring anti-anginal medication, uncontrolled cardiac
arrhythmia(s), severe conduction abnormality, or clinically significant valvular
disease,

2. QTc (F) prolongation > 480 ms,

3. arterial thrombosis or pulmonary embolism within = 6 months before the start of
treatment,

4. myocardial infarction within = 6 months before the start of treatment,

5. pericarditis (any NCI-CTCAE grade), pericardial effusion (NCI-CTCAE Grade = 2),
non-malignant pleural effusion (NCI-CTCAE Grade = 2) or malignant pleural
effusion (NCI-CTCAE Grade = 3) within = 6 months before the start of treatment,

6. Grade = 3 symptomatic congestive heart failure (CHF) or New York Heart
Association (NYHA) criteria Class = II within = 6 months before the start of
treatment.

- Patients who have received a live vaccine within 28 days of planned start of trial
therapy.

- Known hypersensitivity to the active substances or to any of the excipients.

- Presence of a severe concurrent illness or other condition (e.g., psychological,
family, sociological, or geographical circumstances) that does not permit adequate
follow-up and compliance with the protocol.

- Prior treatment with BNT111 and/or with cemiplimab.

Inclusion criteria for entering add-on therapy

- Patients must have confirmed disease progression on monotherapy in Arm 2 or 3 of the
trial.

1. An initial radiological progression needs to be verified by BICR.

2. Radiological progression to be confirmed by two scans 4 to 12 weeks apart unless
initial progression is accompanied by new symptoms, or deterioration of PS not
attributed to toxicity, in which case one scan is sufficient.

- Patients must sign a new ICF to continue with add-on therapy. Informed consent must be
documented before any add-on-specific procedure is performed.

- WOCBP must have a negative serum (beta-hCG) at baseline. Patients that are
postmenopausal or permanently sterilized can be considered as not having reproductive
potential.

- Female patients of reproductive potential must agree to use adequate contraception
during and for 6 months after the last trial drug administration.

- WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during trial starting at screening, during the trial and for 6 months
after receiving the last trial treatment.

- A man who is sexually active with a WOCBP and has not had a vasectomy must agree to
use a barrier method of birth control, e.g., either condom with spermicidal
foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men
must also not donate sperm during the trial and for 6 months after receiving the last
trial treatment.

Exclusion criteria for entering add-on therapy

- Prior toxicity related to trial medication should have resolved to NCI-CTCAE v5.0
Grade = 1 before the start of add-on treatment and may not have led to permanent
discontinuation.

- The time between confirmed PD on monotherapy and start of add-on therapy shall not
exceed 6 weeks.

- Current evidence of new or growing brain or spinal metastases at baseline (lesions
that remained stable during initial treatment are allowed).

- Systemic immune suppression:

1. use of chronic systemic steroid medication (up to 5 mg/day prednisolone
equivalent is allowed); patients using physiological replacement doses of
prednisone for adrenal or pituitary insufficiency are eligible,

2. other clinically relevant systemic immune suppression.

- Presence of cardiovascular, renal, hepatic or any other disease that in the
investigator's opinion, may increase the risks associated with trial participation or
require treatments that may interfere with the conduct of the trial or the
interpretation of trial results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
Accrual to date
Final
184
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Border Medical Oncology - East Albury
Recruitment hospital [2] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [3] 0 0
Melanoma Institute Australia - Sydney
Recruitment postcode(s) [1] 0 0
2640 - East Albury
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
2060 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Germany
State/province [8] 0 0
Bremen
Country [9] 0 0
Germany
State/province [9] 0 0
Essen
Country [10] 0 0
Germany
State/province [10] 0 0
Freiburg
Country [11] 0 0
Germany
State/province [11] 0 0
Hannover
Country [12] 0 0
Germany
State/province [12] 0 0
Heidelberg
Country [13] 0 0
Germany
State/province [13] 0 0
Kiel
Country [14] 0 0
Germany
State/province [14] 0 0
Leipzig
Country [15] 0 0
Germany
State/province [15] 0 0
Mainz
Country [16] 0 0
Germany
State/province [16] 0 0
Mannheim
Country [17] 0 0
Germany
State/province [17] 0 0
Nürnberg
Country [18] 0 0
Germany
State/province [18] 0 0
Tübingen
Country [19] 0 0
Germany
State/province [19] 0 0
Würzburg
Country [20] 0 0
Italy
State/province [20] 0 0
Bari
Country [21] 0 0
Italy
State/province [21] 0 0
Bologna
Country [22] 0 0
Italy
State/province [22] 0 0
Candiolo
Country [23] 0 0
Italy
State/province [23] 0 0
Meldola
Country [24] 0 0
Italy
State/province [24] 0 0
Napoli
Country [25] 0 0
Italy
State/province [25] 0 0
Padova
Country [26] 0 0
Italy
State/province [26] 0 0
Rome
Country [27] 0 0
Italy
State/province [27] 0 0
Siena
Country [28] 0 0
Italy
State/province [28] 0 0
Turin
Country [29] 0 0
Poland
State/province [29] 0 0
Gdansk
Country [30] 0 0
Poland
State/province [30] 0 0
Kraków
Country [31] 0 0
Poland
State/province [31] 0 0
Szczecin
Country [32] 0 0
Poland
State/province [32] 0 0
Tomaszów Mazowiecki
Country [33] 0 0
Poland
State/province [33] 0 0
Warsaw
Country [34] 0 0
Poland
State/province [34] 0 0
Lódz
Country [35] 0 0
Spain
State/province [35] 0 0
A Coruña
Country [36] 0 0
Spain
State/province [36] 0 0
Badalona
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
El Palmar
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Santander
Country [41] 0 0
Spain
State/province [41] 0 0
Santiago De Compostela
Country [42] 0 0
Spain
State/province [42] 0 0
Sevilla
Country [43] 0 0
Spain
State/province [43] 0 0
Valencia
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Glasgow
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Manchester
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BioNTech SE
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, randomized, multi-site, Phase II, interventional trial designed to
evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed
death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients
with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will
be delineated in single agent calibrator arms. Patients will be randomized in a 2:1:1 ratio
to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3
(cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who
experience centrally verified disease progression under single agent treatment, may be
offered addition of the other compound to the ongoing treatment after re-consent.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04526899
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
BioNTech Responsible Person
Address 0 0
BioNTech SE
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04526899