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Clinical Trial Finder

Search Results

Adjuvant Therapy of Completely Resected Merkel Cell Carcinoma With Immune Checkpoint Blocking Antibodies vs Observation

Study Purpose

Primary objective: To estimate the efficacy of adjuvant nivolumab monotherapy in completely resected MCC patients.Primary endpoint: Disease-free survival (DFS) rate evaluated at 12, 24 and 48 months after date of randomization.Secondary Objectives: To describe the safety profile and additional efficacy parameters of the nivolumab treatment in MCC.Secondary endpoints:

  • - Adverse events according to CTCAE, Version 4.0 criteria, that are related to the administration of nivolumab.
  • - Disease-free survival (DFS) - Overall survival (OS) and OS rates at 12, 24 and 48 months after randomization.
Explorative Endpoints:
  • - Distant-metastases-free survival (DMFS) and DMFS rate at 12, 24 and 48 months after randomization.
  • - Identification and validation of prognostic/predictive biomarkers.
- Quality of life (EORTC QLQ-C30) until 24 months after randomization

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The patient is willing and able to give written informed consent. 2. Central histological confirmation of diagnosis of Merkel cell carcinoma (MCC). 3. All MCC manifestations have been completely resected by surgery within 12 weeks before enrolment. 4. No currently present metastases (as confirmed by standard imaging studies (e.g. suggested by S2k guidelines)). 5. No previous systemic therapy for MCC. 6. Required values for initial laboratory tests:
  • - WBC ≥ 2000/uL.
  • - ANC ≥ 1000/uL.
  • - Platelets ≥ 75 x 103/uL.
  • - Hemoglobin ≥ 8 g/dL (≥ 80 g/L) - Creatinine ≤ 2.0 x ULN.
  • - AST/ALT ≤ 2.5 x ULN.
  • - Total Bilirubin ≤ 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL) 7.
ECOG performance status 0 or 1. 8. No active or chronic infection with HIV, Hepatitis B (HBV) or C (HCV). 9. Men and women, ≥ 18 years of age. 10. Women of childbearing potential (WOCBP) must be using an adequate method of contraception (Pearl-Index < 1) to avoid pregnancy during treatment phase and for additional 5 months after the last dose of nivolumab, in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of nivolumab. 11. Men of fathering potential must be using an adequate method of contraception to avoid conception and for 7 months after the last dose of nivolumab in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

1. Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease requiring systemic steroids (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, autoimmune vasculitis); autoimmune motor neuropathy. 2. Other serious illnesses, e.g., serious infections requiring i.v. antibiotics. 3. The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immune deficient condition. 4. Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of nivolumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea. 5. Any non-oncology vaccine therapy for up to 1 month before or after any dose of nivolumab. 6. A history of prior or current treatment with a T cell potentiating agent (e.g. IL-2, interferon, anti-CTLA-4, anti-CD137, anti-PD1, anti-PD-L1, or anti-OX40 antibody). 7. Chronic use of immunosuppressive agents or systemic corticosteroids. 8. Women of childbearing potential (WOCBP), defined above in Section 5.1, who:
  • - are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for additional 5 months after the last dose of investigational product.
  • - have a positive pregnancy test at baseline.
  • - are pregnant or breastfeeding.
9. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures. 10. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness. 11. Men of reproductive potential unwilling to use an adequate method to avoid pregnancy for additional 7 months after the last dose of investigational product. 12. Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02196961
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Prof. Dr. med. Dirk Schadendorf
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dirk Schadendorf, Prof. Dr.
Principal Investigator Affiliation University Hospital, Essen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Active, not recruiting
Countries Germany, Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Merkel Cell Carcinoma
Additional Details

This is an international, open-label, randomized, multicenter phase II study to assess the efficacy of adjuvant nivolumab therapy in completely resected MCC patients. In the initial trial design, the immune modulating treatment was based on CTLA-4 blockade by ipilimumab; however, the advent of PD-1/PD-L1 blockade in the palliative treatment of MCC (presented at AACR, ASCO and ESMO) dramatically changed the treatment environment to an extent that applying treatments other than by PD-1/PD-L1 blockade had become very difficult. Moreover, the side effects of PD-1/PD-L1 blocking are far less frequent than side effects of ipilimumab. Consequently, randomization into the previous Ipilimumab treatment arm A was stopped. New patients will be randomized to nivolumab treatment instead. Patients randomized already into the Ipilimumab-arm will be evaluated descriptively for efficacy and safety. Patients already randomized into the observation arm (arm B) will be evaluated together with the newly randomized arm B-patients. A total of 177 patients with completely resected MCC will be enrolled over a recruitment period of 36 months into this trial, and randomized 2:1 as mentioned above. Patients will be stratified by sex, age, and stage of disease. Examinations and Follow-up Phase: The disease will be assessed at baseline, and thereafter every 12 weeks according to the current German guidelines for the management of MCC patients for 24 months after randomization, or until withdrawal of informed consent, lost to follow-up, or death, whichever occurs first. In addition, the patient's quality of life will be evaluated at baseline (pretreatment visit) and every 3 months until 24 months after randomization using a standard questionnaire (EORTC QLQC30). After 24 months, additional FU visits (or phone calls) will be conducted 6-monthly recording survival and tumor status including subsequent therapies until withdrawal of informed consent, lost to follow-up, death or end of study, whichever occurs first. End of study is defined as 48 months post LPFV (last patient first visit = date of randomization). Same methods of assessment (e.g. ultrasonography, CT or MRI scans) used at baseline will be used during follow-up.

Arms & Interventions

Arms

No Intervention: Observation

After complete resection of Merkel cell carcinoma, patients randomized to the observational arm will be observed only

Experimental: Nivolumab

After complete resection of Merkel cell carcinoma, patients randomized to the treatment arm will receive nivolumab at a fixed dose of 480 mg by IV infusion every 4 weeks for up to one year (i.e.13 doses).

Interventions

Drug: - Nivolumab

adjuvant treatment of completely resected Merkel cell carcinoma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital Essen, Dermatology, Essen, NRW, Germany

Status

Address

University Hospital Essen, Dermatology

Essen, NRW, 45122

Charité Universitätsmedizin Berlin, Berlin, Germany

Status

Address

Charité Universitätsmedizin Berlin

Berlin, , 10117

Elbeklinikum Buxtehude, Buxtehude, Germany

Status

Address

Elbeklinikum Buxtehude

Buxtehude, , 21614

University Hospital Dresden, Dermatology, Dresden, Germany

Status

Address

University Hospital Dresden, Dermatology

Dresden, , 01307

HELIOS Klinikum Erfurt, Erfurt, Germany

Status

Address

HELIOS Klinikum Erfurt

Erfurt, , 99089

Universitätsklinikum Freiburg, Freiburg, Germany

Status

Address

Universitätsklinikum Freiburg

Freiburg, , 79104

SRH Wald-Klinikum Gera, Gera, Germany

Status

Address

SRH Wald-Klinikum Gera

Gera, , 07548

Hannover Medical School, Hannover, Germany

Status

Address

Hannover Medical School

Hannover, , 30625

Heidelberg, Germany

Status

Address

National Centre for Tumour Diseases (NCT)

Heidelberg, , 69120

Kiel, Germany

Status

Address

University Hospital Schleswig-Holstein, Kiel

Kiel, , 24105

Leipzig, Germany

Status

Address

Universitätsklinikum Leipzig Klinik u. Poliklinik f. Dermatologie, Venerologie u. Allergologie

Leipzig, , 04103

Mainz, Germany

Status

Address

Universitätsklinikum Mainz Hautklinik und Poliklinik

Mainz, , 55131

Mannheim, Germany

Status

Address

Universitätsklinikum Mannheim Klinik f. Dermatologie, Venerologie u. Allergologie

Mannheim, , 68167

University Hospital München (LMU), Munich, Germany

Status

Address

University Hospital München (LMU)

Munich, , 80337

Münster, Germany

Status

Address

Universitätsklinikum Münster Zentrale Studienkoordination für innovative Dermatologie (ZID)

Münster, , 48149

Specialist clinic in Hornheide, Münster, Germany

Status

Address

Specialist clinic in Hornheide

Münster, , 48157

Universitätsklinikum Regensburg, Regensburg, Germany

Status

Address

Universitätsklinikum Regensburg

Regensburg, , 93053

University Hospital Tübingen, Tübingen, Germany

Status

Address

University Hospital Tübingen

Tübingen, , 72076

Würzburg, Germany

Status

Address

Universitätsklinikum Würzburg Klinik u. Poliklinik f. Dermatologie, Venerologie u. Allergologie

Würzburg, , 97080

Amsterdam, Netherlands

Status

Address

The Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital (NKI/AVL)

Amsterdam, , 1066 CX

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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