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Adrenal Cortical CarcinomaPhase 2INTERVALNCT07085572

Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer

A Phase 2 study testing Cemiplimab in people with Adrenal Cortical Carcinoma, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This clinical trial is a single-arm, non-randomized, prospective phase II study. The study aims to evaluate if the maintenance immunotherapy with cemiplimab in patients with AdrenoCortical Carcinoma (ACC), who obtained disease response or stabilization after first-line chemotherapy, may delay/prevent disease… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adrenal Cortical Carcinoma
What is being tested?
Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteItaly
Study dates
18 Sep 2025to Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and females >18 years of age;
  • Patients with histologically confirmed ACC;
  • Previous induction therapy with EDP-M followed by cytoreductive surgery if indicated;
  • No disease progression after first line 4-6 EDP-M cycles;
  • An ECOG PS of 0, 1;
  • Adequate organ and bone marrow function documented by:
Show all 20Show fewer
  • Hemoglobin >9.0 g/dL
  • ANC >1.5 x 109/L
  • Platelet count >75 x 109/L
  • Serum creatinine <1.5 ULN or estimated CrCl >30 mL/min
  • Adequate hepatic function:
  • Total bilirubin <1.5 x ULN;
  • AST and ALT both <3 x ULN;
  • ALP <2.5 x ULN; Note: For patients with Gilbert's syndrome, total bilirubin ≤3x ULN. Gilbert's syndrome must be documented appropriately as past medical history.
  • Women of child-bearing potential (physiologically capable of becoming pregnant) that must agree to follow instructions for methods of contraception (including at least one highly effective contraception method, see study protocol) for the duration of treatment with study drug, and after discontinuation of treatment as long as mitotane plasma levels are detectable and, in any case, at least for 6 months post treatment completion; must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug;
  • Women must not be breastfeeding;
  • Males that must agree to follow instructions for methods of contraception (see study protocol) for the duration of treatment with study drug, and then for a total of 6 months post treatment completion. In addition, male patients must not donate sperm for the time period specified above;
  • Willing and able to comply with clinic visits and study-related procedures;
  • Willing and able to provide informed consent signed by study patient or legally acceptable representative;
  • Able to understand and complete study-related questionnaires.

Who cannot join

  • History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 5 years;
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor;
  • Administration of a live vaccine within 30 days of the first dose of study treatment;
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs);
  • Diagnosis of immunodeficiency or systemic steroid therapy (i.e., dosing exceeding 10 mg of prednisone or equivalent). In case of mitotane treatment, a maximum steroid supplementation of 75 mg of cortone acetate (or equivalent hydrocortisone dose) will be accepted;
  • Uncontrolled HIV, Hepatitis B or Hepatitis C (see protocol for details);
Show all 17Show fewer
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis;
  • Active infection requiring systemic therapy;
  • Significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty / stenting / bypass grafting within the last 6 months OR CHF NYHA Class II-IV or history of CHF NYHA Class III or IV;
  • Pregnancy or breastfeeding;
  • Continued sexual activity in women of childbearing potential (physiologically capable of becoming pregnant) or sexually active men who are unwilling to practice highly effective contraception (including at least one highly effective contraception method, see study protocol) prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose;
  • History of active tuberculosis (TB, Bacillus Tuberculosis);
  • Untreated brain metastasis that may be considered active.
  • Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.
  • Patients with a history of solid organ transplant (exception: corneal transplant)
  • Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.
  • ECOG PS ≥ 2

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aldo Roccaro, MD, PhD contact

00390303996851

clinicaltrialcenter@asst-spedalicivili.it

Italy1 site, 1 recruiting

  • S.C. Oncologia - ASST Spedali Civili di Brescia

    Brescia, Brescia, 25123

    Recruiting

Other trials in Italy

About this study

This clinical trial is a single-arm, non-randomized, prospective phase II study.

The study aims to evaluate if the maintenance immunotherapy with cemiplimab in patients with AdrenoCortical Carcinoma (ACC), who obtained disease response or stabilization after first-line chemotherapy, may delay/prevent disease progression.

The study will be conducted at ASST Spedali Civili Hospital, Brescia - Italy.

Read the detailed description

Adrenocortical carcinoma (ACC) is a rare malignancy affecting around 0.7-2 persons per one million population per year.

The only pharmacological approach approved by FDA and EMA for the treatment of ACC is mitotane, which has an adrenolytic effect causing adrenocortical insufficiency. So, the drug should be administered in association with glucocorticoid replacement for the purpose only of restoring the daily cortisol requirement.

Few therapeutic alternatives are available for metastatic ACC patients failing one to two lines of systemic treatment, so immunotherapy could represent a potential new treatment. The immune checkpoint inhibitors are the most promising immunotherapy agents in cancer pharmacology and have been also investigated in ACC. Bases on results of some clinical studies, immunotherapy has achieved long-term control in a small proportion of patients with metastatic ACC. We need to identify the patient subset destined to benefit most from this therapy and at what point in the therapeutic sequence of adrenal carcinoma should immunotherapy be introduced. We also need to implement strategies to overcome the intrinsic immuno-resistance of ACC.

The current strategy in the management of advanced ACC is the administration of the EDP (etoposide, doxorubicin, cisplatin) scheme associated with mitotane followed by maintenance mitotane in patients not progressing on chemotherapy. Maintenance immunotherapy could be administered in combination with mitotane, enhancing its efficacy. In addition, the powerful adrenolytic effect of mitotane could keep cortisol production inhibited, facilitating the efficacy of immunotherapy.

Maintenance therapy with cemiplimab in ACC patients after first-line chemotherapy may result in enhanced antitumor activity while avoiding potential interactions, including cross-resistance and cumulative toxicity.

Being tested
Cemiplimab
Medical subject headings
Adrenocortical Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07085572
Study groupRoleWhat they receive
Cemiplimab added to the standard maintenance therapy with mitotaneExperimentalNot described
Receives: Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of efficacy of cemiplimab as a maintenance immunotherapy on PFS in patients with advanced ACC with no disease progression after 4-6 EDP-M cycles

    Proportion of patients free from progression at 6 months after the end of first-line chemotherapy

    Measured: 36 months

Secondary outcomes (3)

  1. Evaluation of the effect of cemiplimab as a maintenance therapy on Overall Survival (OS)

    The time from the date of the study start to the date of death due to any cause will be measured.

    Measured: 36 months

  2. Evaluation of the effect of cemiplimab on patients' Quality of Life (QoL)

    The QoL will be assesed by EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) questionnaire.

    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: 36 months

  3. Evaluation of the safety profile of maintenance cemiplimab therapy

    The safety profile of maintenance cemiplimab therapy will be evaluated by the frequency of Adverse Effects (AEs) and laboratory abnormalities as graded by NCI CTCAE v5.0.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start18 Sep 2025
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07085572
Sponsor's protocol ID
NP 6502
Other IDs
2024-520449-21-00
Acronym
INTERVAL
Status last verified
Jul 2025
First submitted
16 Jul 2025
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Powles T, Park SH, Caserta C, Valderrama BP, Gurney H, Ullen A, Loriot Y, Sridhar SS, Sternberg CN, Bellmunt J, Aragon-Ching JB, Wang J, Huang B, Laliberte RJ, di Pietro A, Grivas P. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After >/=2 Years of Follow-Up. J Clin Oncol. 2023 Jul 1;41(19):3486-3492. doi: 10.1200/JCO.22.01792. Epub 2023 Apr 18.

    PubMed 37071838

  • Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte R, Wang J, Huang B, Davis C, Fowst C, Costa N, Blake-Haskins JA, di Pietro A, Grivas P. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020 Sep 24;383(13):1218-1230. doi: 10.1056/NEJMoa2002788. Epub 2020 Sep 18.

    PubMed 32945632

  • Cosentini D, Grisanti S, Dalla Volta A, Lagana M, Fiorentini C, Perotti P, Sigala S, Berruti A. Immunotherapy failure in adrenocortical cancer: where next? Endocr Connect. 2018 Dec;7(12):E5-E8. doi: 10.1530/EC-18-0398.

    PubMed 30400026

  • Le Tourneau C, Hoimes C, Zarwan C, Wong DJ, Bauer S, Claus R, Wermke M, Hariharan S, von Heydebreck A, Kasturi V, Chand V, Gulley JL. Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN solid tumor trial. J Immunother Cancer. 2018 Oct 22;6(1):111. doi: 10.1186/s40425-018-0424-9.

    PubMed 30348224

  • Klein O, Senko C, Carlino MS, Markman B, Jackett L, Gao B, Lum C, Kee D, Behren A, Palmer J, Cebon J. Combination immunotherapy with ipilimumab and nivolumab in patients with advanced adrenocortical carcinoma: a subgroup analysis of CA209-538. Oncoimmunology. 2021 Apr 12;10(1):1908771. doi: 10.1080/2162402X.2021.1908771.

    PubMed 33889439

  • McGregor BA, Campbell MT, Xie W, Farah S, Bilen MA, Schmidt AL, Sonpavde GP, Kilbridge KL, Choudhury AD, Mortazavi A, Shah AY, Venkatesan AM, Bubley GJ, Siefker-Radtke AO, McKay RR, Choueiri TK. Results of a multicenter, phase 2 study of nivolumab and ipilimumab for patients with advanced rare genitourinary malignancies. Cancer. 2021 Mar 15;127(6):840-849. doi: 10.1002/cncr.33328. Epub 2020 Nov 20.

    PubMed 33216356

  • Carneiro BA, Konda B, Costa RB, Costa RLB, Sagar V, Gursel DB, Kirschner LS, Chae YK, Abdulkadir SA, Rademaker A, Mahalingam D, Shah MH, Giles FJ. Nivolumab in Metastatic Adrenocortical Carcinoma: Results of a Phase 2 Trial. J Clin Endocrinol Metab. 2019 Dec 1;104(12):6193-6200. doi: 10.1210/jc.2019-00600.

    PubMed 31276163

  • Bedrose S, Miller KC, Altameemi L, Ali MS, Nassar S, Garg N, Daher M, Eaton KD, Yorio JT, Daniel DB, Campbell M, Bible KC, Ryder M, Chintakuntlawar AV, Habra MA. Combined lenvatinib and pembrolizumab as salvage therapy in advanced adrenal cortical carcinoma. J Immunother Cancer. 2020 Jul;8(2):e001009. doi: 10.1136/jitc-2020-001009.

    PubMed 32737143

  • Habra MA, Stephen B, Campbell M, Hess K, Tapia C, Xu M, Rodon Ahnert J, Jimenez C, Lee JE, Perrier ND, Boraddus RR, Pant S, Subbiah V, Hong DS, Zarifa A, Fu S, Karp DD, Meric-Bernstam F, Naing A. Phase II clinical trial of pembrolizumab efficacy and safety in advanced adrenocortical carcinoma. J Immunother Cancer. 2019 Sep 18;7(1):253. doi: 10.1186/s40425-019-0722-x.

    PubMed 31533818

  • Naing A, Meric-Bernstam F, Stephen B, Karp DD, Hajjar J, Rodon Ahnert J, Piha-Paul SA, Colen RR, Jimenez C, Raghav KP, Ferrarotto R, Tu SM, Campbell M, Wang L, Sabir SH, Tapia C, Bernatchez C, Frumovitz M, Tannir N, Ravi V, Khan S, Painter JM, Abonofal A, Gong J, Alshawa A, McQuinn LM, Xu M, Ahmed S, Subbiah V, Hong DS, Pant S, Yap TA, Tsimberidou AM, Dumbrava EEI, Janku F, Fu S, Simon RM, Hess KR, Varadhachary GR, Habra MA. Phase 2 study of pembrolizumab in patients with advanced rare cancers. J Immunother Cancer. 2020 Mar;8(1):e000347. doi: 10.1136/jitc-2019-000347.

    PubMed 32188704

  • Grisanti S, Cosentini D, Lagana M, Volta AD, Palumbo C, Massimo Tiberio GA, Sigala S, Berruti A. The long and winding road to effective immunotherapy in patients with adrenocortical carcinoma. Future Oncol. 2020 Dec;16(36):3017-3020. doi: 10.2217/fon-2020-0686. Epub 2020 Aug 28. No abstract available.

    PubMed 32857613

  • Raj N, Zheng Y, Kelly V, Katz SS, Chou J, Do RKG, Capanu M, Zamarin D, Saltz LB, Ariyan CE, Untch BR, O'Reilly EM, Gopalan A, Berger MF, Olino K, Segal NH, Reidy-Lagunes DL. PD-1 Blockade in Advanced Adrenocortical Carcinoma. J Clin Oncol. 2020 Jan 1;38(1):71-80. doi: 10.1200/JCO.19.01586. Epub 2019 Oct 23.

    PubMed 31644329

  • Cremaschi V, Abate A, Cosentini D, Grisanti S, Rossini E, Lagana M, Tamburello M, Turla A, Sigala S, Berruti A. Advances in adrenocortical carcinoma pharmacotherapy: what is the current state of the art? Expert Opin Pharmacother. 2022 Aug;23(12):1413-1424. doi: 10.1080/14656566.2022.2106128. Epub 2022 Aug 3.

    PubMed 35876101

  • Fassnacht M, Assie G, Baudin E, Eisenhofer G, de la Fouchardiere C, Haak HR, de Krijger R, Porpiglia F, Terzolo M, Berruti A; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Adrenocortical carcinomas and malignant phaeochromocytomas: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Nov;31(11):1476-1490. doi: 10.1016/j.annonc.2020.08.2099. Epub 2020 Aug 27. No abstract available.

    PubMed 32861807

  • Berruti A, Baudin E, Gelderblom H, Haak HR, Porpiglia F, Fassnacht M, Pentheroudakis G; ESMO Guidelines Working Group. Adrenal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii131-8. doi: 10.1093/annonc/mds231. No abstract available.

    PubMed 22997446

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab in people with Adrenal Cortical Carcinoma, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aldo Roccaro, MD, PhD (00390303996851, clinicaltrialcenter@asst-spedalicivili.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of efficacy of cemiplimab as a maintenance immunotherapy on PFS in patients with advanced ACC with no disease progression after 4-6 EDP-M cycles (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07085572, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.

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