Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ≥2 Years of Follow-Up.
Thomas Powles, Se Hoon Park, Claudia Caserta...
https://pubmed.ncbi.nlm.nih.gov/37071838Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07085572
Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer
Led by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Updated on 2025-10-06
31
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating cemiplimab as a maintenance immunotherapy for patients with advanced Adrenocortical Carcinoma (ACC) who have achieved disease response or stabilization after first-line chemotherapy. This phase II, single-arm study aims to determine if cemiplimab can delay or prevent the progression of ACC, a rare cancer with limited treatment options, especially after failure of standard therapies. The study is conducted at ASST Spedali Civili Hospital in Brescia, Italy. Participants will receive cemiplimab at a dose of 350 mg intravenously every three weeks as maintenance treatment following initial chemotherapy with the EDP-M regimen (etoposide, doxorubicin, cisplatin plus mitotane). The study explores whether adding cemiplimab can enhance antitumor activity while avoiding additional toxicities or drug interactions. Maintenance therapy continues for up to 36 months, monitoring patient response and safety. During the study, participants will undergo regular assessments to monitor progression-free survival, overall survival, quality of life, and safety of cemiplimab maintenance therapy. These evaluations include clinical visits, laboratory tests to confirm organ and bone marrow function, and questionnaires assessing quality of life. The trial lasts up to 36 months, with continuous follow-up to gather data on treatment effects and tolerability.
CONDITIONS
Brief Title
Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female patients aged over 18 years
- Histologically confirmed diagnosis of Adrenocortical Carcinoma
- Previous treatment with EDP-M chemotherapy followed by cytoreductive surgery if indicated
- No disease progression after 4 to 6 cycles of first-line EDP-M chemotherapy
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function as specified by defined blood and liver test thresholds
- Women of childbearing potential must agree to use effective contraception and have a negative pregnancy test before starting treatment
- Women must not be breastfeeding
- Male patients must agree to use contraception and avoid sperm donation during treatment and for six months after
- Willing and able to comply with clinic visits and study procedures
- Able to provide informed consent
- Able to understand and complete study questionnaires
You will not qualify if you...
- History of recent or active malignancy except certain cured cancers with no disease for at least 5 years
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or similar immune treatments
- Receipt of live vaccine within 30 days before starting study treatment
- Active autoimmune disease requiring systemic treatment in past 2 years
- Diagnosis of immunodeficiency or recent systemic steroid therapy exceeding specified doses
- Uncontrolled HIV, Hepatitis B or C infection
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Significant cardiovascular disease within last 6 months or severe heart failure
- Pregnancy or breastfeeding
- Inability or unwillingness to practice effective contraception as required
- History of active tuberculosis
- Untreated active brain metastases
- Known allergy to cemiplimab or its components
- History of solid organ transplant except corneal transplant
- Prior stem cell transplantation
- Eastern Cooperative Oncology Group performance status 2 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 36 months
Participants receive cemiplimab as maintenance immunotherapy combined with standard mitotane therapy after completing first-line chemotherapy without disease progression.
Infusions every 3 weeks with regular clinic visits for treatment administration and monitoring
Trial Site Locations
Total: 1 location
1
S.C. Oncologia - ASST Spedali Civili di Brescia
Brescia, Brescia, Italy, 25123
Actively Recruiting
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Research Team
A
Aldo Roccaro, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma.
Thomas Powles, Se Hoon Park, Eric Voog...
https://pubmed.ncbi.nlm.nih.gov/32945632Immunotherapy failure in adrenocortical cancer: where next?
Deborah Cosentini, Salvatore Grisanti, Alberto Dalla Volta...
https://pubmed.ncbi.nlm.nih.gov/30400026Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN solid tumor trial.
Christophe Le Tourneau, Christopher Hoimes, Corrine Zarwan...
https://pubmed.ncbi.nlm.nih.gov/30348224Combination immunotherapy with ipilimumab and nivolumab in patients with advanced adrenocortical carcinoma: a subgroup analysis of CA209-538.
Oliver Klein, Clare Senko, Matteo S Carlino...
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Bradley Alexander McGregor, Matthew T Campbell, Wanling Xie...
https://pubmed.ncbi.nlm.nih.gov/33216356Nivolumab in Metastatic Adrenocortical Carcinoma: Results of a Phase 2 Trial.
Benedito A Carneiro, Bhavana Konda, Rubens B Costa...
https://pubmed.ncbi.nlm.nih.gov/31276163Combined lenvatinib and pembrolizumab as salvage therapy in advanced adrenal cortical carcinoma.
Sara Bedrose, Kevin Charles Miller, Lina Altameemi...
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Mouhammed Amir Habra, Bettzy Stephen, Matthew Campbell...
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https://pubmed.ncbi.nlm.nih.gov/32188704