Clinical Trials

Clinical Trials Unit at HC Cancer Center
Every advance against cancer began in a clinical trial

The Clinical Trials Unit at HC Cancer Center aims to provide cancer patients with access to cutting-edge therapies.
 
Clinical trials are essential in the search for safer and more effective medical treatments, they represent an open door to innovation and hope for patients.
 
Participation in a clinical trial does not entail additional costs for patients, and they can be carried out in both public and private hospitals.
 
Consulting your doctor is the first step to finding out if there is an opportunity to participate in a clinical trial that could benefit you.

What is a clinical trial

A clinical trial is any clinical research that is conducted in humans to determine or confirm the safety and efficacy of a drug. At the same time, they offer patients the possibility of accessing innovative treatments that could not otherwise be used…
 

Trials are classified according to their phase of development into:

Phase I

First time the drug is given to people, either healthy volunteers or patients with the disease. Its tolerability, toxicity and metabolism are studied, together with preliminary activity data.

Phase II

The drug is given to a small group of people with the disease to assess its safety and efficacy.

Phase III

Carried out in more patients to confirm its safety and efficacy, usually against the standard treatment. If the results are positive, marketing authorisation can be requested.

Phase IV

Once the drug is already on the market, more information is gathered on its safety, long-term effects and/or new indications.

New drugs

Clinical trials are strictly controlled and have to be approved beforehand by a Drug Research Ethics Committee (CEIm for its Spanish acronym) as well as by the Spanish Agency for Medicines and Health Products (AEMPS for its Spanish acronym). Similarly, they can only be carried out in centres with experience and have very strict requirements.
 
As a result, the administration of the research drug, similarly to those already marketed, is not without risks, but these usually consist of mild side effects.

Participation in a clinical trial is voluntary, the participant must meet a series of requirements (inclusion and exclusion criteria) which will determine whether or not they can participate in the clinical trial.
 
Each clinical trial has specific inclusion and exclusion criteria.
 
Participation in a clinical trial should not generate any additional cost for patients, they can be carried out in both public and private centres, which often work as a network.
 
Your doctor can provide you with information on any trials which might benefit you, at any point during your disease.

 

Active clinical trials

Lung cancer · Immunotherapy vaccine (ARTEMIA) Now recruiting
Trial titleRandomised, open-label phase 3 trial, comparing the efficacy and safety of OSE2101 versus docetaxel in HLA-A2 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with secondary resistance to Immune Checkpoint Inhibitor (ICI)
ConditionMetastatic non-small cell lung cancer
PhasePhase III
Age18 years and over
Protocol codeOSE2101C302 (ARTEMIA)
EudraCT / EUCT number2023-509340-10-00
SponsorOSE Immunotherapeutics
Principal investigatorDr. José Manuel Trigo Pérez

View full trial information

Head and neck cancer · First-line immunotherapy Now recruiting
Trial title“A phase 3 study to evaluate petosemtamab plus pembrolizumab in first-line treatment of head and neck cancer”
ConditionMetastatic or recurrent head and neck cancer
PhasePhase III
Age18 years and over
Protocol codeMCLA-158-CL03
EudraCT / EUCT number2023-510323-30-00
SponsorMerus N.V.
Principal investigatorDr. José Manuel Trigo Pérez

View full trial information

Advanced melanoma · Latest-generation immunotherapy Recruitment closed
Trial titleRandomised, double-blind, parallel-group study to compare the pharmacokinetics, efficacy, safety and immunogenicity of JPB898 (a proposed biosimilar of nivolumab) and Opdivo®, approved in the USA and the EU, in combination with Yervoy® in participants with previously untreated advanced (unresectable/metastatic) melanoma
ConditionUnresectable stage III or metastatic stage IV melanoma
PhasePhase III
Age18 years and over
Protocol codeCJPB898A12301
EudraCT / EUCT number2023-507865-24-00
SponsorHexal AG
Principal investigatorDr. José Manuel Trigo Pérez

View full trial information

Non-small cell lung cancer · Acasunlimab (ABBIL1TY NSCLC-06) Recruitment closed
Trial titleProspective, open-label, randomised phase 3 trial of Acasunlimab (GEN1046) in combination with Pembrolizumab versus Docetaxel in subjects with PD-L1-positive metastatic non-small cell lung cancer after treatment with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy (ABBIL1TY NSCLC-06)
ConditionPD-L1-positive metastatic non-small cell lung cancer
PhasePhase III
Age18 years and over
Protocol codeGCT1046-06
EudraCT / EUCT number2024-512998-27-00
SponsorGenmab
Principal investigatorDr. José Manuel Trigo Pérez

View full trial information

Lung cancer with high PD-L1 expression · Ivonescimab (HARMONi-7) Now recruiting
Trial title“A phase 3, randomised, double-blind, multiregional study of ivonescimab versus pembrolizumab as first-line treatment for metastatic non-small cell lung cancer in patients whose tumours have high PD-L1 expression (HARMONi-7)”
ConditionMetastatic non-small cell lung cancer with high PD-L1 expression
PhasePhase III
Age18 years and over
Protocol codeSMT112-3007
EudraCT / EUCT number2024-518629-14-00
SponsorSummit Therapeutics
Principal investigatorDr. José Manuel Trigo Pérez

View full trial information

Frequently asked questions about clinical trials

What is a clinical trial?

A clinical trial is any clinical research conducted in humans to determine or confirm the safety and efficacy of a drug. It also gives patients the possibility of accessing innovative treatments that could not otherwise be used.

Who can take part in a clinical trial?

Participation is voluntary and each study has its own inclusion and exclusion criteria: the type and stage of the tumour, age, previous treatments or certain biological markers. The medical team reviews each case and confirms whether these criteria are met before the trial begins.

Does taking part in a clinical trial cost anything?

No. Taking part in a clinical trial does not entail any additional cost for the patient, and trials can be carried out in both public and private hospitals. In HC Cancer Center trials, the study’s medical procedures are covered by the sponsor.

How do I know if there is a suitable trial for my case?

Consulting your doctor is the first step to finding out whether there is an opportunity to take part in a clinical trial that could benefit you. You can also email us at ensayos.clinicos@hcmarbella.com or call us on +34 626 662 752: our team will review your case and explain whether any of our active trials fits your situation.

Can I leave a clinical trial if I change my mind?

Yes. Taking part in a clinical trial is always voluntary: you can withdraw at any time without having to give a reason, and this will not affect the medical care you receive.

What checks are carried out during a clinical trial?

Clinical trials are strictly controlled. Before they begin, they must be approved by a Drug Research Ethics Committee (CEIm) and by the Spanish Agency for Medicines and Health Products (AEMPS), and they can only be carried out in experienced centres with very strict requirements. During the study, patients receive continuous care and follow-up from the specialist medical team.

Do all patients receive the investigational drug?

It depends on the design of each study. Phase III trials, like the ones we are currently running at HC Cancer Center, usually compare a standard treatment with an innovative one, so participants may receive either. Before signing the consent form, the medical team explains in detail how treatment is assigned in that particular trial.

How can I request information about clinical trials at HC Marbella?

You can email us at ensayos.clinicos@hcmarbella.com, call us on +34 626 662 752 or fill in the information request form on our website. Our team will contact you to learn about your case and explain the next steps.

Oncology Consultants

Dr. Cantero González, Alexandra
Specialist in Medical Oncology
Clinical Specialism in Lung Cancer and Cancer ImmunotherapySpecialist in Medical Oncology
Clinical Dedication in Breast and Gynecological Cancer

Dr. Ponce Aix, Santiago
Medical Oncology Specialist
Clinical Dedication in Lung Cancer
Precision medicine
Cancer immunotherapy

Tel.: +34 952 908 628
+34 609 148 799

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