642TiP Phase II CA184-585 (INSPIRE) trial of ipilimumab with nivolumab for molecular-selected patients with castration-resistant prostate cancer

Mehra, Niven; Kloots, Iris S. H.; Slootbeek, Peter H. J.; Brok, M. den; Adema, Gosse J.; Kerkmeijer, Linda G.W.; Smeenk, Robert Jan; Westdorp, Harm; Bloemendal, Haiko J.; Schalken, Jack A.; Erp, Nielka P. van; Binder, Mascha; Vries, Jolanda De; Gerritsen, Winald R.

doi:10.1016/j.annonc.2021.08.1155

Cited by 2 publications

(1 citation statement)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Ongoing clinical trials are currently investigating the effect of ipilimumab and nivolumab for highly selected patients with mCRPC and a positive immune signature, aiming to achieve an increased clinical benefit (eg, NCT02601014 and NCT04717154). 29 30 Preliminary results from the NEPTUNES trial (NCT03061539) reported a favourable response rate in highly selected and pretreated patients, with a composite response rate of 26%.…”

Section: Discussionmentioning

confidence: 99%

Randomised phase II trial of stereotactic body radiotherapy in combination withcheckpoint inhibitors in metastatic castration-resistantprostate cancer (CheckPRO): a study protocol

et al. 2023

View full text Add to dashboard Cite

IntroductionImmunotherapy with checkpoint inhibitors (CPIs) has revolutionised cancer treatment but has no convincing effect in metastatic castration-resistant prostate cancer (mCRPC). It has been suggested that a combination of CPI and hypofractionated stereotactic body radiotherapy (SBRT) may work synergistically, and recent trials have supported this. We hypothesise that adding SBRT to CPI treatment can improve response rates in patients with mCRPC.Methods and analysisThe CheckPRO trial is an open-label, randomised, two-stage, phase II trial. We aim to enrol and randomise 80 evaluable patients with mCRPC who progressed following ≥2 lines of treatment. Enrolment started in November 2019 with 38 months expected enrolment period. The participants receive treatment for 52 weeks including four cycles of ipilimumab and nivolumab with or without concomitant SBRT (24 Gray in three fractions) to a single soft tissue or bone metastasis, followed by 10 cycles of nivolumab. Participants are followed until progression, death, or for 12 months after the end of treatment.Co-primary endpoints are the objective response rate and prostate-specific antigen (PSA) response rate. Secondary endpoints include safety, radiographic progression-free survival, clinical benefit rate, duration of response, PSA-progression-free survival beyond 12 weeks, quality of life and overall survival. Exploratory endpoints include translational analyses of tumour biopsies and consecutive blood samples. Biopsies from metastatic sites are collected at baseline, before the third treatment and at the end of treatment. Blood sampling for immune monitoring and circulating tumour DNA is performed consecutively at baseline and every radiographic assessment.Ethics and disseminationThis study follows the Helsinki Declaration and is approved by the Danish Ethics Committee System (journal no. H-19016100). All participants must receive written and oral information and provide a signed informed consent document prior to inclusion. The study results will be published in an international peer-review journal.Trial registration numberEudraCT number: 2018-003461-34. clinicaltrials.gov IDNCT05655715.

show abstract

Section: Discussionmentioning

confidence: 99%

Randomised phase II trial of stereotactic body radiotherapy in combination withcheckpoint inhibitors in metastatic castration-resistantprostate cancer (CheckPRO): a study protocol

et al. 2023

View full text Add to dashboard Cite

show abstract

The Prostate Cancer Immune Microenvironment, Biomarkers and Therapeutic Intervention

Zhang

Campbell

Stylli

et al. 2022

Uro

View full text Add to dashboard Cite

Advanced prostate cancers have a poor survival rate and a lack of effective treatment options. In order to broaden the available treatments, immunotherapies have been investigated. These include cancer vaccines, immune checkpoint inhibitors, chimeric antigen receptor T cells and bispecific antibodies. In addition, combinations of different immunotherapies and with standard therapy have been explored. Despite the success of the Sipuleucel-T vaccine in the metastatic, castrate-resistant prostate cancer setting, other immunotherapies have not shown the same efficacy in this population at large. Some individual patients, however, have shown remarkable responsiveness to these therapies. Therefore, work is underway to identify which populations will respond positively to therapy via the identification of predictive biomarkers. These include biomarkers of the immunologically active tumour microenvironment and biomarkers indicative of high neoantigen expression in the tumour. This review examines the constitution of the prostate tumour immune microenvironment, explores the effectiveness of immunotherapies, and finally investigates how therapy selection can be optimised by the use of biomarkers.

show abstract

642TiP Phase II CA184-585 (INSPIRE) trial of ipilimumab with nivolumab for molecular-selected patients with castration-resistant prostate cancer

Cited by 2 publications

References 0 publications

Randomised phase II trial of stereotactic body radiotherapy in combination withcheckpoint inhibitors in metastatic castration-resistantprostate cancer (CheckPRO): a study protocol

Randomised phase II trial of stereotactic body radiotherapy in combination withcheckpoint inhibitors in metastatic castration-resistantprostate cancer (CheckPRO): a study protocol

The Prostate Cancer Immune Microenvironment, Biomarkers and Therapeutic Intervention

Contact Info

Product

Resources

About