Study Comparing ABP 206 and Nivolumab for Patients with Unresectable or Metastatic Melanoma

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What is this study about?

This clinical trial is focused on studying a type of skin cancer called unresectable or metastatic melanoma. This means the melanoma cannot be removed by surgery or has spread to other parts of the body. The study is comparing two treatments: ABP 206 and OPDIVO® (nivolumab). Both treatments are given through an intravenous infusion, which means they are administered directly into a vein.

The purpose of the study is to evaluate how effective and safe ABP 206 is compared to OPDIVO® in patients who have not received any previous treatment for their advanced melanoma. Participants in the study will receive either ABP 206 or OPDIVO® for a period of up to 24 months. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments. The study will monitor the response to the treatment, including any changes in the size of the melanoma, and will also track any side effects or immune reactions that may occur.

Throughout the study, participants will have regular check-ups to assess their health and the progress of their melanoma. The study aims to provide valuable information on the effectiveness of ABP 206 compared to OPDIVO® in treating unresectable or metastatic melanoma, potentially offering new insights into treatment options for this condition.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either ABP 206 or OPDIVO (nivolumab).

Both medications are administered as a solution for infusion through a vein (intravenous administration).

2 treatment administration

The patient will receive the assigned medication at a dosage of 10 mg/mL.

The frequency and duration of administration will be determined by the study protocol, which aims to evaluate the efficacy and safety of the treatments.

3 monitoring and assessments

Throughout the study, the patient’s response to the treatment will be monitored. This includes regular assessments to measure the size of the melanoma and any changes in the condition.

The primary goal is to observe the objective response by week 49.

4 secondary assessments

Secondary assessments will include evaluating the objective response at week 17, progression-free survival (PFS), overall survival (OS), and duration of response (DOR).

Safety assessments will focus on any adverse events that occur during the treatment.

5 immunogenicity and pharmacokinetics

The study will also assess the immunogenicity, which involves checking for the presence of anti-drug antibodies (ADAs).

Pharmacokinetic assessments will measure the concentration of ABP 206 and nivolumab in the blood.

6 completion of the study

The study is expected to conclude by May 15, 2025.

Upon completion, the data collected will be analyzed to determine the efficacy and safety of the treatments.

Who Can Join the Study?

  • The participant can be a man or a woman and must be at least 18 years old at the time of screening.
  • The participant must have a confirmed diagnosis of stage III (unresectable) or stage IV melanoma, which is a type of skin cancer that cannot be removed by surgery or has spread to other parts of the body.
  • The participant must have a measurable disease, meaning the cancer can be measured in size using specific guidelines called RECIST.
  • Tumor tissue from the removed cancer site must be available for testing to help with the study.
  • The participant must not have received any previous treatment that affects the whole body for advanced melanoma. However, previous treatments given after surgery or before surgery are allowed if they were completed at least 6 months before joining the study. Previous radiation therapy to relieve symptoms is allowed if it was completed at least 2 weeks before starting the study treatment.
  • For women who are not at least 2 years past menopause or not surgically unable to have children, a negative pregnancy test is required during screening and at the start of the study.
  • The participant must have a good general health status, with a score of 0 or 1 on a scale used to assess daily living abilities called the Eastern Cooperative Oncology Group (ECOG) performance status.
  • The participant’s blood test results must meet specific criteria within 14 days before joining the study, including:
    • White blood cell count of at least 2000 per microliter.
    • Neutrophils (a type of white blood cell) of at least 1500 per microliter.
    • Platelets (cells that help with blood clotting) of at least 100,000 per microliter.
    • Hemoglobin (a protein in red blood cells) of at least 9.0 grams per deciliter.
    • Creatinine (a waste product in the blood) within normal limits or creatinine clearance (a measure of kidney function) greater than 40 milliliters per minute.
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT), which are liver enzymes, must be no more than 3 times the upper limit of normal.
    • Total bilirubin (a substance made by the liver) must be no more than 1.5 times the upper limit of normal, except for those with Gilbert Syndrome, who must have total bilirubin less than 3.0 milligrams per deciliter.
  • The participant must be able to understand and sign a consent form approved by an ethics committee before any study-specific procedures are done.

Who Cannot Join the Study?

  • Patients who have already received treatment for their advanced melanoma cannot participate.
  • Patients with other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and is not currently active, cannot participate.
  • Patients with certain infections, like HIV or hepatitis, cannot participate.
  • Patients who are taking medications that might interfere with the study treatment cannot participate.
  • Patients with a history of severe allergic reactions to similar treatments cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Da Luz S.A. Lisbon Portugal
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Champalimaud Clinical Centre Lisbon Portugal
Hopital Ambroise Pare Boulogne-Billancourt France
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital General Universitario De Valencia Valencia Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Spitalul Clinic Judetean De Urgenta Sibiu Sibiu Romania
Centro Hospitalar de Setubal E.P.E. Setubal Portugal
Amphia Hospital Breda The Netherlands
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Oncolab S.R.L. Craiova Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Spitalul Municipal Ploiesti Ploiesti Romania
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
University Of Pecs Pecs Hungary
Azienda Sanitaria Locale Napoli 1 Centro Naples Italy
KBC Zagreb Zagreb Croatia
Centre Hospitalier Universitaire Rouen Rouen France
University Teaching Hospital Markusovszky Szombathely Hungary
Clinical Medical Center Osijek Osijek Croatia
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Philipps-Universitaet Marburg Marburg Germany
Universita’ Politecnica Delle Marche Ancona Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola Rome Italy
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Fondazione Luigi Maria Monti Rome Italy
Hospital De Santa Maria E.P.E. Lisbon Portugal
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Hospital San Pedro De Alcantara Caceres Spain
Hospital De Sao Francisco Xavier Lisbon Portugal
Radiotherapy Center Cluj S.R.L. Floresti Romania
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
MD Anderson Cancer Center Madrid Spain
Groupe Hospitalier Rance Emeraude Saint-Malo France
University Of Tartu Tartu Estonia
Ospedale “S. Vincenzo” Taormina (Italy) Italy
Policlinico di Bari, AOU Consorziale Policlinico di Bari Bari Italy
ASST Ospedale Maggiore di Crema Crema Italy
Cvmlyi Honmsuczisv Uvhxhdmxdyooy Db Dddye Dijon France
Idtvrsfb Rveptxyyu Pil Lb Saucdf Det Thvfkw Dyuu Axpzicq Ifki Sdhann Meldola Italy
Moxaymx Cswueo Gmnk Skqbup Ploiesti Romania
Uzgahtfqrq Hjnpvuhu Cbwlrde Cologne Germany
Amskqyq Okncxjrqqwt Uwzzocmzsuidx Sggjtl Siena Italy
Avofjkw Oycyqexkgey Nfkizwnyb Sd Aeqtjnm E Bpakhh E C Ayzkbr Arvnqolkgkf Alexandria Italy
Gtauoy Upupckmwhg Fxdmakexe Frankfurt Germany
Awpqjpl Uqw Inoax Dd Razxom Eqcfci Reggio Emilia Italy
Hxdutfjo Db Lx Ssgkc Cntc I Sefy Plc Barcelona Spain
Acdwgyj Olwgeqdhyyr Pcze Gzfplmda Xjnza Bergamo Italy
Iseszo Ilrjebpm Fivaftbdphfdh Ohzlmhwuhxx Rome Italy
Hzsfuaod Uirxgxnqlkpar Hrgyrlwg Tkddp y Pzifag Irnpkiva Cckatq ddrhrsasydvbewhkw (uudz Badalona Spain
Hkpcmaao Vyjc dbtxpvaw Barcelona Spain
Vkqooxyuv iahlcvgt Vvkrvrcw uorzuoyedbml luktyomci Snhmcbsj kbtigvs fxcamljg Nsnjnwnvozlv vdinv cvxtkku Vilnius Lithuania
Ewfk Trhfitt Ccbiirk Hhztmeoj Tallin Estonia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Croatia Croatia
Not recruiting
15.08.2023
Czechia Czechia
Not recruiting
15.08.2023
Estonia Estonia
Not recruiting
15.08.2023
France France
Not recruiting
15.08.2023
Germany Germany
Not recruiting
15.08.2023
Hungary Hungary
Not recruiting
15.08.2023
Italy Italy
Not recruiting
15.08.2023
Lithuania Lithuania
Not recruiting
15.08.2023
Portugal Portugal
Not recruiting
15.08.2023
Romania Romania
Not recruiting
15.08.2023
Spain Spain
Not recruiting
15.08.2023
The Netherlands The Netherlands
Not recruiting
15.08.2023

Trial locations

Investigated drugs:

ABP 206 is an investigational medication being studied for its effectiveness in treating patients with melanoma that cannot be surgically removed or has spread to other parts of the body. This medication is being compared to an existing treatment to see how well it works in patients who have not received any previous systemic treatment for their advanced melanoma.

Opdivo (Nivolumab) is a medication already used in the treatment of melanoma. It works by helping the immune system to recognize and attack cancer cells. In this study, it serves as a comparison to evaluate the effectiveness and safety of the investigational medication ABP 206 in patients with advanced melanoma.

Unresectable or Metastatic Melanoma – This is a type of skin cancer that has spread beyond the original site and cannot be removed through surgery. It often begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, lungs, liver, brain, and bones. The spread of melanoma to distant sites is referred to as metastasis, which can complicate treatment and management. Symptoms may include changes in existing moles, the appearance of new pigmented or unusual-looking growths on the skin, and, in advanced stages, symptoms related to the affected organs. Early detection and monitoring of skin changes are crucial in managing the progression of this disease.

Trial ID:
2023-503288-40-00
Protocol code:
20210031
Trial Phase:
Therapeutic confirmatory (Phase III)

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