CLINIC OF ONCOLOGY MEDICAL STUDY AND INVESTIGATION

What is a “clinical study”?

A clinical study is a confirmation process of a medication already demonstrated to be effective and safe. The study medication is compared with a placebo (a pharmacological inactive substance) in case of (absence or presence of) any standard therapy in order to confirm whether this medication is more effective and may be approved for administration to the general public in everyday clinical practice.

In case an already standard treatment proven to benefit survival, the study compares the study medication with this standard treatment, first in relation to the standard therapy to the exclusion of anything else, and then adding a new medication to the standard treatment so that greater benefit for survival or response to the disease may be confirmed, in relation to the exclusive standard treatment.

What is the benefit to any patient by participating in a clinical study?

The participation in clinical studies is connected to multiple advantages, usually guaranteeing a high level of treatment approach and monitoring through an internationally determined strict framework that specifies a protocol on an individual study basis.

The participation in clinical studies may yield the following results:

1. Access to contemporary therapies combining internationally approved treatments through the addition of the new treatment regimens under study, without cost to the patient or his/her insurance company.
   The patient has access to hospital services covered by the study (blood tests, imaging, biopsies, brief hospitalizations, full in-patient hospitalizations and oncological monitoring by the study physicians) at no charge to the patient.
   Many times, depending on the clinical study, the patient may undergo free of any charges state-of-the-art imaging, laboratory or genetic controls, which being very expensive procedures are never covered by insurance funds.
   Furthermore, many international clinical studies cover transportation expenses charged to patients between the hospital and the patient’s residence, facilitating patient access from various parts in Greece to high-quality treatment centers, in a time of extreme financial difficulty.
2. Patients may receive modern and promising treatments, before they become universally accessible, provided that such therapies demonstrate through the study procedure their therapeutic value attaining a complete cure in the end and improvement in the quality of life and overall survival.
   This is an exceptionally significant prospect especially for persons with often incurable, metastatic malignancies.
3. Patients may receive therapies, in case the standard treatment choices are limited or exhausted.
4. Persons with no insurance coverage may undergo the best possible approved therapies combined with the treatment under study in a high-quality hospital setting, free of charge.

Participation in a clinical study may be advisable only in case such study is the best possible solution to the treatment of the disease, after complete and detailed information to the person concerned. Such participation is always voluntary. At the same time it is not binding on anyone even after the participant initially accepted in writing to participate in such study. Any discontinuation of further participation is at the discretion of the participant and/or his/her attending physician.

In international clinical studies the administration of medication and the paraclinical examinations regarding the protocol are free, at no charge to the insurance carrier.

EARLY ACCESS PROGRAMS

The early access programs involve new medication treatments with demonstrated benefits in the targeted treatment of malignancies, approved by the FDA in the USA and/or by EMA in Europe; however, they are not yet currently in circulation in Greece since they have not been ascribed a price.
Access to these medications is possible through these programs, a long time prior to their pricing and prescription, offering their benefits from an early time to patients in need without any charge to them (in some case without even a charge to their insurance agency as it is made freely available by the pharmaceutical company producing it; however, this case applies to a very minimal number of patients).

The early access programs are not clinical studies.

At this stage there is no active early access program in our Clinic.

• Early access program for non-metastatic castration-resistant prostate cancer. Free administration and access to apalutamide to non-metastatic castration-resistant prostate cancer. (This program is now completed).
• Early access program for microcytic lung cancer – extensive disease, first-line study.
• Free administration/ access to atezolizumab to already established chemotherapy treatment with etoposide and platinum.

(This program is now completed. The medication is already available by the National Organization for Health Care Services EOPYY)

RESEARCH PROGRAMS

Prognostic and predictive value of tumor molecular alteration in patients with prostate cancer TR_9/2.

(Approval of the Hospital Scientific Board is pending for administration of the program to prostate cancer patients)

How can I get information on availability of a clinical study, an early access program or any research program that may be appropriate for my case?

You may search the Metropolitan Hospital site or the Oncology Medical Study and Investigation Clinic site, the clinical studies, the early access programs or research programs, which are active in this phase or are expected to be activated. You may then communicate with the Clinic oncologists and arrange for an appointment regarding the prospect of induction into any of the available schemes, depending on the nature of your problem.

In case you are already attended by a physician, either s/he may be informed concerning the value of clinical studies and discuss such participation matters with you or refer you to any member of our Team at the Oncology Medical Study and Investigation Clinic.

• Head and neck cancer
• Central nervous system (CNS) cancer
• Gynecological (GY) cancer (ovaries, uterus/endometrium, uterine cervix)
• Breast cancer
• Genitourinary cancer (prostate, kidney, urothelial cases

PROSTATE CANCER

Clinical Study Phase 3: PRESIDE

This is a study for the evaluation of the treatment benefits with enzalutamide after disease onset in males starting treatment with dosetaxel after exacerbation of castration-resistant metastatic prostate cancer, while exclusively receiving enzalutamide (September 2015).

(The process of patient induction is now completed)

Clinical Study CO39385

Phase 3, polycentric, randomized, placebo-controlled, double-blind study with atezolizumab combined with enzalutmaide compared with enzalutamide exclusively in patients with castration-resistant metastatic prostate cancer after failure of treatment with androgen biosynthesis inhibitors and failure or inability or denial of treatment with chemotherapy scheme with taxane. (October 2017: This study is now completes)

Clinical Study CO39303

Phase 3, randomized, double-blind, placebo-controlled, polycentric study for the treatment with ipatasertib plus abiterone plus prednisone/prednizolone, in relation with treatment with placebo plus abiterone plus prednisone/prednizolone, to patients with asymptomatic or moderately symptomatic castration-resistant metastatic prostate cancer who have not received any other treatment before (November 2017-). (The process of patient induction is now completed)

Study CONTACT-02_XL184-315

Phase 3, randomized, study administration of cabozantinib combined with atezolizumab compared with second hormonal agent (enzalutamib or abiterone) to high-risk patients suffering from castration-resistant metastatic prostate cancer.
(In anticipation of the study activation and the Center)

KIDNEY CANCER

Non-Invasive Study CPZ034AGR06 Atlas

Prospective observation study, Phase 4 to patients with advanced renal cell carcinoma for the evaluation of the effectiveness and the duration of responses to first-line therapy with pazopanib. (This study is now completed)

BLADDER CANCER – UROTHELIAL CANCER

Clinical Study CA017-78

Phase 3, randomized study of introductory exclusive chemotherapy compared with introductory chemotherapy combined with nivolumab or with nivolumab plus BMS-986205, followed by continued post-operative treatment with nivolumab or nivolumab plus BMS-986205 to patients with non-penetrating bladder cancer.  (This study starts in September 2020. Induction of patient continues. Active study)

Digestive system cancers: Stomach, colorectal and pancreas cancers (GI cancers)

LARGE INTESTINE/ COLORECTAL CANCER

Clinical Study ISO-CC-007
Randomized, polycentric, parallel group study, Phase 3 for the comparison of effectiveness of arfolitixorin compared with leucovorin combined with 5-fluouroacil, oxaliplatin and bevacizumab on patients with advanced colorectal cancer (first-line treatment). (This study is active and patient induction continues)

Clinical Study CA209-8HW

Phase 3b, randomized clinical study of monotherapy with nivolumab compared with combination of nivolumab and ipilimumab or chemotherapy of the research physician’s choice on patients with metastatic colorectal cancer and microsatellite instability (MSI-H or d MMR. (This study involves patients on first-line therapy or any other line of therapy – multiple therapy patients). (This study is active and patient induction continues)

Small-cell (microcytic or non-microcytic) lung cancer

MICROCYTIC LUNG CANCER

Clinical Study GO41767

This is a Phase 3, randomized, double-blind, placebo-controlled comparison study of a therapy with atezolizumab and carboplatin and etoposide with or without tiragolumab (anti-TIGIT antibody) to patients with extensive-stage microcytic lung cancer who have never received any other treatment. (This study is active and patient induction continues)