Phase
Condition
Cervical Cancer
Small Cell Lung Cancer
Melanoma
Treatment
TransCon TLR7/8 Agonist
Pembrolizumab
Chemotherapy drug
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
At least 18 years of age, or country defined local legal age
Demonstrated adequate organ function at screening
Life expectancy >12 weeks as determined by the Investigator
Female and male participants of childbearing potential who are sexually active mustagree to use highly effective methods of contraception
Participants must have histologically confirmed locally advanced, recurrent, ormetastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of the neoadjuvant cohorts
Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Part 3 and Part 4: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Participants who have undergone treatment with anti-PD-1, anti-PD-L1, oranti-cytotoxic T-lymphocyte-associated protein (CTLA-4) antibody must have a washoutof at least 4 weeks from the last dose and evidence of disease progression perinvestigator assessment before Cycle 1 Day 1 (C1D1) with the exception of theneoadjuvant cohorts
Participants who have previously received an immunotherapy prior to C1D1 must haveany immune-related toxicities resolved to ≤Grade 1 or baseline (prior to theimmunotherapy) to be eligible, with the exception of participants on well controlledphysiologic endocrine replacement
Part 3: Neoadjuvant cohorts: participants must have completely resectable disease
Exclusion
Key Exclusion Criteria:
Symptomatic central nervous system metastases and/or carcinomatous meningitis
Active autoimmune diseases, regardless of need for immunosuppressive treatment, withthe exception of participants well controlled on physiologic endocrine replacement
Any uncontrolled bacterial, fungal, viral, or other infection
Significant cardiac disease
A marked clinically significant baseline prolongation of QT/QTc interval (e.g.,repeated demonstration of a QTc interval >480 ms) [CTCAE Grade 1]) usingFridericia's QT correction formula
Positive for human immunodeficiency virus (HIV) or has known active hepatitis B or Cinfection
Known hypersensitivity to any study treatment(s) used in the specific studypart/cohort
Participants who have been previously treated with IL-2 or IL-2 variants (allparticipants)
Systemic immunosuppressive treatment with the exception for patients oncorticosteroid taper (for example, for chronic obstructive pulmonary diseaseexacerbation).
Vaccination with live, attenuated vaccines within 4 weeks of C1D1
Treatment with any other anti-cancer systemic treatment (approved orinvestigational) or radiation therapy within 4 weeks of C1D1
Part 3: Other active malignancies within the last 2 years
Women who are breastfeeding or have a positive serum pregnancy test during screening
Study Design
Study Description
Connect with a study center
Ascendis Pharma Investigational Site
Adelaide, 5042
AustraliaActive - Recruiting
Ascendis Pharma Investigational Site
Frankston, 3199
AustraliaActive - Recruiting
Ascendis Pharma Investigational Site
Southport, 4215
AustraliaActive - Recruiting
Ascendis Pharma Investigational Site
Toorak Gardens, 05065
AustraliaTerminated
Ascendis Pharma Investigational Site
Waratah, 2298
AustraliaActive - Recruiting
Ascendis Pharma Investigational Site
Wilrijk, 2610
BelgiumActive - Recruiting
Ascendis Pharma Investigational Site
Montréal, H2X-0A9
CanadaSite Not Available
Ascendis Pharma Investigational Site
Toronto, M5G 2C4
CanadaActive - Recruiting
Ascendis Pharma Investigational Site
Cuneo, 12100
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Firenze, 50134
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Grosseto, 58100
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Lido Di Camaiore, 55041
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Livorno, 57124
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Meldola, 47014
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Milan, 20141
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Modena, 41124
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Roma, 00167
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Torino, 10126
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Turin, 10060
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Verona, 37134
ItalyActive - Recruiting
Ascendis Pharma Investigational Site
Seongnam-si, 13620
Korea, Republic ofActive - Recruiting
Ascendis Pharma Investigational Site
Seoul, 06351
Korea, Republic ofActive - Recruiting
Ascendis Pharma Investigational Site
Kraków, 31-501
PolandActive - Recruiting
Ascendis Pharma Investigational Site
Poznań, 60693
PolandActive - Recruiting
Ascendis Pharma Investigational Site
Warszawa, 02-781
PolandActive - Recruiting
Ascendis Pharma Investigational Site
Singapore, 217562
SingaporeActive - Recruiting
Ascendis Pharma Investigational Site
Barcelona, 08023
SpainActive - Recruiting
Ascendis Pharma Investigational Site
L'Hospitalet De Llobregat, 08908
SpainActive - Recruiting
Ascendis Pharma Investigational Site
Madrid, 28041
SpainActive - Recruiting
Ascendis Pharma Investigational Site
Murcia, 30120
SpainActive - Recruiting
Ascendis Pharma Investigational Site
Málaga, 29010
SpainActive - Recruiting
Ascendis Pharma Investigational Site
Oviedo, 33011
SpainActive - Recruiting
Ascendis Pharma Investigational Site
Pamplona, 31008
SpainActive - Recruiting
Ascendis Pharma Investigational Site
Sevilla, 41014
SpainActive - Recruiting
Ascendis Pharma Investigational Site
Valencia, 46014
SpainActive - Recruiting
Ascendis Pharma Investigational Site
Taipei, 11259
TaiwanTerminated
Ascendis Pharma Investigational Site
Los Angeles, California 90067
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Springfield, Illinois 62702
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Louisville, Kentucky 40202
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Boston, Massachusetts 02114
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Morristown, New Jersey 07960
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
New York, New York 10032
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Huntersville, North Carolina 28078
United StatesTerminated
Ascendis Pharma Investigational Site
Canton, Ohio 44718
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Nashville, Tennessee 37203
United StatesActive - Recruiting
Ascendis Pharma Investigational Site
Richmond, Virginia 23298
United StatesActive - Recruiting
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