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The Effect of Previous Pregnancies in Patients With Gynecological Neoplasms Treated With PD-1/PD-L1 Inhibitors

NCT06945601 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-04-25

No results posted yet for this study

Summary

Despite the fact that immunotherapy has radically changed the therapeutic landscape in multiple types of tumors, to date the only predictive factor for response to treatment with immune checkpoint inhibitors (ICI), although with many limitations and very different specificity among different pathologies, remains the expression of PD-L1. Several meta- analyses of randomized studies have shown that the female sex is associated with less benefit compared to the male sex in patients with melanoma and NSCLC. Reviewing the available data in the literature, this reduced efficacy is confirmed only in the mono- immunotherapy settings, while when chemo-immune combinations are administered, women seem to benefit more than men. Pregnancy, being associated with immunological changes that can last over time (e.g., mechanisms of immuno-tolerance, antigen sharing between the placenta and neoplasia, fetal microchimeric cells, etc.), could partly explain the impact of sex on the outcome of immune checkpoint inhibitors. In particular, some mechanisms of immunotolerance, such as the increase of T-regulatory cells specific to oncofetal antigens in the endometrium, could potentially suggest a lower efficacy of immunotherapy in women. The current study, by characterizing the impact of previous pregnancies on oncological outcomes, could contribute to providing the basis for future research aimed at defining the biological mechanisms underlying the effect of pregnancy on the immune system and the efficacy of immune checkpoint inhibitors.

The study has an observational, retrospective/prospective, multicenter design. Female patients with endometrial and cervical cancer will be included. All these patients will be treated with ICIs either as monotherapy or in combination with chemo-immunotherapy. Clinical and oncological anamnesis information will be collected for each patient (type of neoplasm, line of therapy, age at the start of therapy, weight, height, smoking habits, comorbidities, performance status, number and site of metastases, concomitant non- oncological therapies); anatomical-pathological parameters will also be collected (level of PD-L1 expression, molecular and mutational profile of the tumor). Additionally, information regarding the woman's pregnancy and fertility history will be gathered (age at menarche/menopause, number of pregnancies, age at first pregnancy, age at last pregnancy, any HRT or contraceptive therapy, any gynecological surgery).

Conditions

  • Gynecologic Cancers

Interventions

DRUG

ICI monotherapy or combinations of chemo- immunotherapy

ICI monotherapy or combinations of chemo- immunotherapy

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2030-05-31
Completion
2030-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06945601 on ClinicalTrials.gov