Tremelimumab immunotherapy for Liver Cancer

University of Chicago Hospital, Chicago, IL
Liver CancerTremelimumab immunotherapy - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new cancer treatment involving two drugs given after TheraSphere, to see if it is more effective at treating HCC than TheraSphere alone.

Eligible Conditions
  • Liver Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

2 Primary · 53 Secondary · Reporting Duration: Treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is randomized).

Baseline Visit
Pre-treatment volumes and absorbed doses to the following volumes of interest (VOIs) using 99mTc-MAA SPECT/CT imaging and Simplicit90Y dosimetry software will be determined.
Month 18
Change from baseline in Albumin Bilirubin (ALBI) score.
Change from baseline in Child-Pugh score.
Change from baseline in Eastern Cooperative Oncology Group (ECOG) score.
Change from baseline in QoL by EQ-5D.
Change from baseline in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [GGT], alkaline phosphatase [ALK], bilirubin, albumin).
Change from baseline in quality of life (QoL) by FACT-Hep.
Baseline up to post-treatment imaging visit.
Correlation between normal tissue absorbed doses in Gy determined by 99mTc-MAA SPECT/CT and by Y-90 PET.
Correlation between tumoral absorbed doses in Gy determined by 99mTc-MAA SPECT/CT and Y-90 PET.
Determination of dose volume histogram (DVH) for tumoral VOIs and normal liver tissue VOIs, using 99mTc-MAA SPECT/CT and Y-90 PET.
Month 18
Alpha fetoprotein (AFP) response.
Month 18
Time to best response (CR or PR) according to localized mRECIST, mRECIST, RECIST 1.1.
Month 18
Complete response rate (CRR) according to localized mRECIST, mRECIST, RECIST 1.1.
Month 18
Hepatic progression free survival (hPFS) by mRECIST, RECIST 1.1.
Hepatic time to progression (hTTP) according to mRECIST, RECIST 1.1.
Month 18
Overall survival (OS).
Proportion of patients receiving subsequent treatment for HCC after study treatment, and type of HCC treatment received.
Proportion of patients to undergo curative therapy (transplantation or resection).
Whole liver and remnant liver volumes at baseline and follow-up imaging assessments measured using Simplicit90Y software.
Month 18
Progression free survival (PFS) according to localized mRECIST, mRECIST, RECIST 1.1; this will include an evaluation of the PFS rate at 6, 12, 18 and 24 months.
Time to progression (TTP) according to localized mRECIST, mRECIST, RECIST 1.1.
Month 18
Objective Response Rate (ORR)
Month 18
Correlation between normal tissue absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, assessing impact on tumor response, survival and number of Grade 3 or higher AEs and SAEs.
Correlation between normal tissue absorbed doses in Gy, determined by Y-90 PET, assessing impact on tumor response, survival and number of Grade 3 or higher AEs and SAEs.
Correlation between tumoral absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, assessing impact on tumor response, survival and number of Grade 3 or higher AEs and SAEs.
Correlation between tumoral absorbed doses in Gy, determined by Y-90 PET, assessing impact on tumor response, survival and number of Grade 3 or higher AEs and SAEs.
Disease Control Rate (DCR) according to localized mRECIST, mRECIST, RECIST 1.1.
ORR according to mRECIST, RECIST 1.1.
Reason for starting subsequent HCC treatment.
Time to subsequent HCC treatment (local or systemic therapy).
Month 18
Duration of complete response (DoCR) according to localized mRECIST, mRECIST, RECIST 1.1.
Month 18
Duration of disease control (DoDC) according to localized mRECIST, mRECIST, RECIST 1.1.
Month 18
Duration of response (DoR)
Month 18
DoR according to mRECIST, RECIST 1.1.
Month 18
Correlation between normal tissue absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, assessing impact on tumor response, survival and number of AEs and SAEs.
Correlation between normal tissue absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, with all primary and secondary efficacy and safety endpoints.
Correlation between normal tissue absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, with efficacy and safety endpoints.
Correlation between normal tissue absorbed doses in Gy, determined by Y-90 PET, assessing impact on tumor response, survival and number of AEs and SAEs.
Positron-Emission Tomography
Correlation between normal tissue absorbed doses in Gy, determined by Y-90 PET, with efficacy and safety endpoints.
Correlation between tumoral absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, assessing impact on tumor response, survival and number of AEs and SAEs.
Correlation between tumoral absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, with all primary and secondary efficacy and safety endpoints.
Correlation between tumoral absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, with efficacy and safety endpoints.
Correlation between tumoral absorbed doses in Gy, determined by Y-90 PET, assessing impact on tumor response, survival and number of AEs and SAEs.
Correlation between tumoral absorbed doses in Gy, determined by Y-90 PET, with all primary and secondary efficacy and safety endpoints.
Correlation between tumoral absorbed doses in Gy, determined by Y-90 PET, with efficacy and safety endpoints.
Number of patients whose TheraSphere treatment was temporarily halted due to an AE.
Post-treatment volumes and absorbed doses to the following volumes of interest (VOIs) using 99mTc-MAA SPECT/CT and Y-90 PET imaging and Simplicit90Y dosimetry software will be determined.
Cognitive Therapy
Progression free survival (PFS) according to localized mRECIST, mRECIST, RECIST 1.1, and iRECIST; this will include an evaluation of the PFS rate at 6, 12, 18 and 24 months.
Proportion of patients suitable to undergo curative therapy (transplantation or resection).
Month 18
Number of adverse events (AEs) and serious adverse events (SAEs).
Number of immune mediated AEs and SAEs.
Number of patients whose durvalumab and/or tremelimumab treatment was temporarily halted, postponed or permanently discontinued due to an AE.
Treatment Visit
Post-treatment volumes and absorbed doses to the following volumes of interest (VOIs) using Y-90 PET imaging and Simplicit90Y dosimetry software will be determined.

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

TheraSphere alone
1 of 2
TheraSphere followed by Durvalumab and Tremelimumab
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Tremelimumab immunotherapy · No Placebo Group · Phase 2

TheraSphere followed by Durvalumab and TremelimumabExperimental Group · 3 Interventions: Tremelimumab immunotherapy, TheraSphere Y-90 glass microsphere therapy, Durvalumab (Imfinzi) immunotherapy · Intervention Types: Drug, Device, Drug
TheraSphere alone
Device
ActiveComparator Group · 1 Intervention: TheraSphere Y-90 glass microsphere therapy · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: treatment (day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is randomized).

Who is running the clinical trial?

Biocompatibles UK LtdIndustry Sponsor
24 Previous Clinical Trials
2,478 Total Patients Enrolled
2 Trials studying Liver Cancer
95 Patients Enrolled for Liver Cancer
Boston Scientific CorporationLead Sponsor
687 Previous Clinical Trials
924,447 Total Patients Enrolled
2 Trials studying Liver Cancer
434 Patients Enrolled for Liver Cancer
Beau Toskich, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
Aiwu Ruth He, MD PhDPrincipal InvestigatorGeorgetown University

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Are there currently vacant spots available to participants in this research study?

"According to clinicaltrials.gov, this experiment is actively seeking patient enrollment and has been since December 1st 2022. The details of the research were last revised on November 18th 2022." - Anonymous Online Contributor

Unverified Answer

What potential adverse effects should be expected from Tremelimumab therapy?

"Our team has evaluated Tremelimumab [immunotherapy](https://www.withpower.com/clinical-trials/immunotherapy) and given it a rating of 2 due to clinical data which implies safety, but not yet efficacy." - Anonymous Online Contributor

Unverified Answer

Is this an innovative research project?

"Tremelimumab immunotherapy has seen an unprecedented level of clinical trial involvement since its first study in 2007. Hosted across 58 countries and 1327 different cities, 340 active trials have been conducted by AstraZeneca alone with 123 studies completing their required Phase 2 drug approval stages." - Anonymous Online Contributor

Unverified Answer

How many individuals have been admitted to participate in this trial thus far?

"This clinical trial necessitates the recruitment of 150 qualified candidates. Those who meet the inclusion criteria may register at either Indiana University in Indianapolis or University of Minnesota in Minneapolis." - Anonymous Online Contributor

Unverified Answer

What conditions does Tremelimumab immunotherapy typically treat?

"Tremelimumab immunotherapy is typically prescribed to treat late stage non-small cell lung cancer that cannot be surgically removed. It can also provide relief for advanced ureter urothelial carcinoma, as well as other conditions not mentioned here." - Anonymous Online Contributor

Unverified Answer

Has Tremelimumab immunotherapy been trialed before?

"The first official investigation of tremelimumab immunotherapy was conducted in 2007 by Research Site. Since then, it has been the subject of 123 completed clinical trials and is presently involved in 340 active studies across Indianapolis, Indiana." - Anonymous Online Contributor

Unverified Answer

Are there a multitude of locations hosting this research program within the state?

"Currently, the trial is running in 7 locations spanning from Indianapolis to Jacksonville. It may be prudent for potential participants to opt for a location closer to home in order to reduce travel time and expenses." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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