819TiP COLIBRI trial (GINECO-CE108b): A multicenter, window study evaluating immune impact and safety of nivolumab in combination with ipilimumab before initial radio-chemotherapy (RTCT) treatment for locally advanced cervix cancer

Kaminsky-Forrett, M-C.; Joly, Florence; Montané, Laure; Roufai, Diana Bello; Savoye, Aude-Marie; Angelergues, Antoine; Hardy-Bessard, A-C.; Reynier, M.A. Mouret; Deluche, Élise; Caux, Christophe; Saintigny, Pierre; Péré, Hélène; Treilleux, Isabelle; Bétrian, Sarah; Lécuru, Fabrice

doi:10.1016/j.annonc.2021.08.1261

Cited by 3 publications

(7 citation statements)

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“…Development of ICIs and other types of immunotherapies in different stages of CC are ongoing (Table 2). [53][54][55][56][57][58][59][60][61][62] Locally advanced cervical cancer…”

Section: Next Stepsmentioning

confidence: 99%

“…Several clinical trials are evaluating the combination of ICI with concomitant radiochemotherapy in locally advanced CC (Table 2). 54,[56][57][58][59] The ENGOT-cx11/KEYNOTE-A18 trial (NCT04221945) 57 is a randomized phase III study assessing the efficacy of radiochemotherapy with pembrolizumab or placebo in the locally advanced setting.…”

Section: Next Stepsmentioning

confidence: 99%

“…66 Different early-phase trials combining ICIs, such as nivolumab and ipilimumab (CHECKMATE 358), 36 durvalumab and tremelimumab (NCT01975831), 37 and balstilimab and zalifrelimab (NCT03495882), 38 in advanced CC progressing after at least one line of treatment have demonstrated promising results. In addition, the COLIBRI study (NCT04256213) 54 is a multicentre, single-arm pilot study assessing the biological impact pre-and post-treatment with nivolumab and ipilimumab just before concurrent radiochemotherapy in patients with squamous cell CC. In patients with International Federation of Gynecology and Obstetrics stage IB3 to IVA CC, standard first-line therapy is concomitant radiochemotherapy.…”

Section: Immune Checkpoint Inhibitor Combinationsmentioning

confidence: 99%

“…As described above, nivolumab and ipilimumab have complementary efficacy action in advanced pretreated CC. 54 Unfortunately, this combination is explored in heavily pretreated patients with limited immune resources. Patients with diagnosis of local disease might not be immune exhausted and thus might benefit more from this combination.…”

Section: Immune Checkpoint Inhibitor Combinationsmentioning

confidence: 99%

“…In the COLIBRI trial, patients received nivolumab at 3 mg/kg and ipilimumab at 1 mg/kg before radiochemotherapy, and nivolumab monotherapy at 480 mg every 4 weeks for 6 months after radiochemotherapy. 54 The aim is to assess the impact of nivolumab and ipilimumab doublet before radiochemotherapy and of the maintenance therapy on the evolution of the CD8+/FOXP3+ ratio of lymphocytes in primary tumour and on the systemic immune response. 54 Beyond anti-CTLA-4/anti-PD-1 doublet, tiragolumab is a novel agent designed to bind to T-cell immunoreceptor with immunoglobulin and ITIM domain (TIGIT).…”

Section: Immune Checkpoint Inhibitor Combinationsmentioning

confidence: 99%

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Pembrolizumab and Chemotherapy in Cervical Cancer: A New Standard of Care?

Lebreton¹,

Saux²,

Méry³

et al. 2022

Oncology &Amp; Haematology

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Cervical cancer (CC) still has a high incidence despite screening programmes and access to human papillomavirus (HPV) vaccination, with a poor prognosis in the advanced setting. Most cases of cervical carcinoma are related to HPV infection. The pathogen-induced nature of the disease, the involvement of genes regulating the immune response and the high grade of immune infiltration provide the rationale to evaluate anti-programmed death-(ligand)1 (PD-[L]1) immune checkpoint inhibitors in CC. This article reviews the promising outcomes of the KEYNOTE-826 phase III trial, which evaluates the addition of pembrolizumab to chemotherapy in patients with PD-L1-positive disease and recurrent, persistent or metastatic cancer of the cervix, leading to an improvement of progression-free survival and overall survival. We also aim to address some outstanding questions and discuss the next steps in immunotherapy for CC.

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“…Development of ICIs and other types of immunotherapies in different stages of CC are ongoing (Table 2). [53][54][55][56][57][58][59][60][61][62] Locally advanced cervical cancer…”

Section: Next Stepsmentioning

confidence: 99%

Section: Next Stepsmentioning

confidence: 99%

Section: Immune Checkpoint Inhibitor Combinationsmentioning

confidence: 99%

Section: Immune Checkpoint Inhibitor Combinationsmentioning

confidence: 99%

Section: Immune Checkpoint Inhibitor Combinationsmentioning

confidence: 99%

See 3 more Smart Citations

Pembrolizumab and Chemotherapy in Cervical Cancer: A New Standard of Care?

Lebreton¹,

Saux²,

Méry³

et al. 2022

Oncology &Amp; Haematology

View full text Add to dashboard Cite

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Window of opportunity with PD1 blockade before chemoradiotherapy for an advanced stage clear cell carcinoma of the cervix

Courtès,

Kountouri,

Wang

et al. 2024

Gynecologic Oncology Reports

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Nivolumab plus chemoradiotherapy in locally-advanced cervical cancer: the NICOL phase 1 trial

et al. 2023

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Concurrent chemoradiotherapy (CRT) with blockade of the PD-1 pathway may enhance immune-mediated tumor control through increased phagocytosis, cell death, and antigen presentation. The NiCOL phase 1 trial (NCT03298893) is designed to determine the safety/tolerance profile and the recommended phase-II dose of nivolumab with and following concurrent CRT in 16 women with locally advanced cervical cancer. Secondary endpoints include objective response rate (ORR), progression free survival (PFS), disease free survival, and immune correlates of response. Three patients experience grade 3 dose-limiting toxicities. The pre-specified endpoints are met, and overall response rate is 93.8% [95%CI: 69.8–99.8%] with a 2-year PFS of 75% [95% CI: 56.5–99.5%]. Compared to patients with progressive disease (PD), progression-free (PF) subjects show a brisker stromal immune infiltrate, higher proximity of tumor-infiltrating CD3+ T cells to PD-L1+ tumor cells and of FOXP3+ T cells to proliferating CD11c+ myeloid cells. PF show higher baseline levels of PD-1 and ICOS-L on tumor-infiltrating EMRA CD4+ T cells and tumor-associated macrophages, respectively; PD instead, display enhanced PD-L1 expression on TAMs, higher peripheral frequencies of proliferating Tregs at baseline and higher PD-1 levels at week 6 post-treatment initiation on CD4 and CD8 T cell subsets. Concomitant nivolumab plus definitive CRT is safe and associated with encouraging PFS rates. Further validation in the subset of locally advanced cervical cancer displaying pre-existing, adaptive immune activation is warranted.

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819TiP COLIBRI trial (GINECO-CE108b): A multicenter, window study evaluating immune impact and safety of nivolumab in combination with ipilimumab before initial radio-chemotherapy (RTCT) treatment for locally advanced cervix cancer

Cited by 3 publications

References 0 publications

Pembrolizumab and Chemotherapy in Cervical Cancer: A New Standard of Care?

Pembrolizumab and Chemotherapy in Cervical Cancer: A New Standard of Care?

Window of opportunity with PD1 blockade before chemoradiotherapy for an advanced stage clear cell carcinoma of the cervix

Nivolumab plus chemoradiotherapy in locally-advanced cervical cancer: the NICOL phase 1 trial

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