A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors (SKYSCRAPER-11)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

18 Sep 2023 → 26 Dec 2025

Decision date (initial)

2024-02-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

External identifiers

EU CT number

2023-508489-14-00

EudraCT number

2022-001157-23

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Pharmacokinetic

To evaluate the safety and tolerability of tiragolumab and atezolizumab intravenous (IV) fixed-dose combination (FDC)

Secondary objectives 2

1. To characterize the pharmacokinetics of tiragolumab and atezolizumab following administration of IV FDC
2. To evaluate the immune response to tiragolumab and atezolizumab following IV FDC administration by measuring anti-tiragolumab and anti-atezolizumab antibodies

Conditions and MedDRA coding

Solid Tumors

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-003418-PIP01-23

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Histologic documentation of locally advanced, recurrent, or metastataic malignancy ineligible for definitive local therapy, for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.
2. Adequate hematologic and end organ function
3. PD-L1-selected tumors, as determined by the investigational VENTANA® PD‑L1 (SP263) IHC assay. Tumor types include: EAC, ESCC, GC, GEJ, HCC, melanoma, NSCLC, RCC, SCCHN, and UBC.
4. Measurable disease per RECIST v1.1
5. Life expectancy ≥12 weeks

Exclusion criteria 6

1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of tiragolumab and atezolizumab IV FDC
2. Prior treatment with CPIs including but not limited to anti-TIGIT, anti-PD-L1, anti-PD-1, anti-CTLA-4
3. Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
4. Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ)
5. Acute infection and/or treatment with systemic antibiotics within 4 weeks of first dose
6. Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) – The severity of CRS will also be determined according to the ASTCTCRS American Society for Transplantation and Cellular Therapy cytokine release syndrome Consensus Grading Scale.

Secondary endpoints 5

1. 1. Area under the concentration time curve of tiragolumab and atezolizumab at Cycle 1
2. 2. Maximum serum concentration (Cmax) of tiragolumab and atezolizumab at Cycle 1
3. 3. Minimum serum concentration (Cmin) of tiragolumab and atezolizumab at Cycle 1
4. 4. Prevalence of anti-drug antibodies (ADAs) to tiragolumab at baseline and the incidence of treatment emergent ADAs to tiragolumab during the study
5. 5. Prevalence of ADAs to atezolizumab at baseline and the incidence of treatment emergent ADAs to atezolizumab during the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 5

Locations

4 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Documents 54 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications