NCT04554030

Impact of Immunotherapy on the Sperm Count of Patients With Cancer

Status unknown Last updated 18 September 2020

What this trial tests

trial testing Evaluate sperm count before and after immunotherapy in Sperm Count, Low in 30 participants. Status unknown.

Timeline

2 January 2020

Primary endpoint
30 September 2021

30 August 2022

Quick facts

Lead sponsor	Hospital Italiano de Buenos Aires
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	30
Start date	2 January 2020
Primary completion	30 September 2021
Estimated completion	30 August 2022
Sites	1 location across Argentina

Drugs / interventions tested

• Evaluate sperm count before and after immunotherapy

Conditions studied

• Sperm Count, Low — all drugs for Sperm Count, Low →

Sponsor

Hospital Italiano de Buenos Aires

Who can join

18 and older, male only, with Sperm Count, Low. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cancer is a public health problem. In recent years, oncology has been revolutionized with the advent of new treatments for different tumor models, mainly immunotherapy directed against cell cycle control points. Numerous inhibitory pathways are incorporated into the immune system to maintain tolerance and homeostasis, and these are collectively known as immunological checkpoints.

The main function of immunological checkpoints is to protect tissues from damage when the immune system is responding to pathogens and maintain tolerance to self antigens (ie, prevent autoimmunity). This is mainly achieved by down-regulation of T cell activation or effector functions. There is increasing evidence to show that a primary mechanism by which tumors evade the immune system is through the participation of immunological checkpoints. This has stimulated the development of many novel agents that modulate immunological checkpoints or other costimulatory receptors.

CTLA-4 is the first receptor of the checkpoint that is successfully selected as immunotherapy. Ipilimumab, an anti-CTLA-4 monoclonal antibody, was the first immunological checkpoint inhibitor to receive FDA approval for the treatment of advanced melanoma.

On the other hand, PD-1 is another receptor for the immune control point, and its ligands, the programmed cell death ligand 1 (PD-L1) and PD-L2, also resulted in important therapeutic advances in cancer immunotherapy.

Unlike CTLA-4, PD-1 is widely expressed and can be found in, in addition to T cells, in B cells and natural killer (NK) cells. The main function of PD-1 is to limit the activity of T cells in peripheral tissues during an inflammatory immune response.

The tumors can exploit this control point, expressing the ligand PD-L1 and generating that the cytotoxic T lymphocytes and the NK cells are anergic and incapable of killing. This up-regulation mechanism of PD-L1 is known in tumors such as melanoma, lung and ovary. Several monoclonal antibodies directed to PD-1 have already received approvals for their clinical use as Nivolumab and Pembrolizumab.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.