Trial: Phase III Study of Rilvegostomig in Com…

Trial Details

Sponsor: AstraZeneca (industry)

Phase: 3

Start date: May 6, 2025

Planned enrollment: 1220

Trial ID: NCT06921785

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Rilvegostomig (AZD2936)

Overview

Rilvegostomig (AZD2936) is an investigational bispecific monoclonal antibody from AstraZeneca that targets PD‑1 and TIGIT. It is being studied across multiple tumor types, with ongoing phase 3 programs including first‑line metastatic non‑squamous NSCLC (ARTEMIDE‑Lung03), adjuvant biliary tract cancer after resection (ARTEMIDE‑Biliary01), first‑line advanced hepatocellular carcinoma (ARTEMIDE‑HCC01), and first‑line HER2‑positive, PD‑L1–positive gastric/GEJ cancer (ARTEMIDE‑Gastric01). (cdek.pharmacy.purdue.edu)

Mechanism of action

Bispecific IgG1 engineered to bind PD‑1 and TIGIT on the same T cell, aiming to augment antitumor immunity beyond PD‑1 blockade alone. The Fc region carries triple mutations (L234F/L235E/P331S) to reduce Fc‑mediated effector function. (cdek.pharmacy.purdue.edu)
Constructed on a DuetMab backbone; the TIGIT arm derives from Compugen’s anti‑TIGIT antibody (COM902). (cdek.pharmacy.purdue.edu)
Early clinical and translational work suggests high receptor occupancy on peripheral T cells at clinically relevant doses. (pmc.ncbi.nlm.nih.gov)

Efficacy

NSCLC (ARTEMIDE‑01, Phase I/II)

CPI‑pretreated cohort (dose escalation/expansion; PD‑L1 TPS ≥1%): among 83 patients, confirmed ORR 4.8% (all partial responses); median PFS 2.1 months (95% CI 2.0–4.1); 27‑week DCR 31.3%. Recommended phase 2 dose (RP2D) 750 mg Q3W. (oncologypro.esmo.org)
CPI‑naïve cohorts:
PD‑L1 TPS 1–49%: ORR 29%; median PFS 6.0 months (95% CI 2.7–8.4); median DOR 6.4 months (95% CI 4.2–NC). (onclive.com)
PD‑L1 TPS ≥50%: ORR 61.8% (95% CI 43.6–77.8%); median PFS 10.2 months (95% CI 6.3–NC); median DOR 10.3 months (95% CI 8.2–NC). Data are from the first analysis of ARTEMIDE‑01 CPI‑naïve parts C/D and remain preliminary. (onclive.com)

Ongoing phase 3 studies (no efficacy readouts yet)

NSCLC: ARTEMIDE‑Lung03 compares rilvegostomig + platinum/pemetrexed vs pembrolizumab + platinum/pemetrexed in first‑line PD‑L1–positive metastatic non‑squamous NSCLC (started November 2024; target n≈878). (cdek.pharmacy.purdue.edu)
Biliary tract cancer (adjuvant): ARTEMIDE‑Biliary01 evaluates rilvegostomig + investigator’s‑choice chemotherapy (capecitabine, S‑1, or gemcitabine/cisplatin) vs placebo + chemotherapy; primary endpoint recurrence‑free survival (JCO abstract TPS4199; enrollment began 2024; planned n≈750). (ascopubs.org)
Hepatocellular carcinoma: ARTEMIDE‑HCC01 compares rilvegostomig + bevacizumab with or without tremelimumab vs atezolizumab + bevacizumab in first‑line advanced HCC (registered as NCT06921785; launched 2025; planned n≈1220). (smartpatients.com)
Gastric/GEJ (HER2+, PD‑L1 CPS ≥1): ARTEMIDE‑Gastric01 (phase 3) tests rilvegostomig + fluoropyrimidine + trastuzumab deruxtecan vs trastuzumab + chemotherapy + pembrolizumab (3‑arm design; recruiting). (cdek.pharmacy.purdue.edu)

Safety

CPI‑pretreated NSCLC (ARTEMIDE‑01 parts A/B): treatment‑related AEs in 54.2% (grade ≥3 in 8.4%); no grade 4/5 treatment‑related AEs; discontinuations 3.6%. (oncologypro.esmo.org)
CPI‑naïve NSCLC (ARTEMIDE‑01 parts C/D): grade ≥3 treatment‑related AEs 10.5%; treatment‑related discontinuations 4.2%; no clear safety differences between 750 mg and 1500 mg Q3W. (onclive.com)

Key trials (selection)

Phase I/II first‑in‑human NSCLC: ARTEMIDE‑01 (NCT04995523). (cdek.pharmacy.purdue.edu)
Phase III first‑line NSCLC: ARTEMIDE‑Lung03 (NCT06627647). (cdek.pharmacy.purdue.edu)
Phase III adjuvant BTC: ARTEMIDE‑Biliary01 (NCT06109779). (ascopubs.org)
Phase III first‑line HCC: ARTEMIDE‑HCC01 (NCT06921785). (smartpatients.com)
Phase III first‑line HER2+ gastric/GEJ: ARTEMIDE‑Gastric01 (NCT06764875). (cdek.pharmacy.purdue.edu)

HealthScout AI Analysis

Goal: To determine whether rilvegostomig plus bevacizumab, with or without tremelimumab, improves overall survival compared with the standard atezolizumab plus bevacizumab regimen as first-line therapy for advanced hepatocellular carcinoma; and to characterize progression-free survival, response outcomes, safety, and the influence of PD-L1 expression on efficacy.

Patients: Adults with unresectable, locally advanced or metastatic HCC not amenable to curative or locoregional therapies, ECOG 0–1, BCLC B (not eligible for LRT) or C, Child-Pugh A, at least one measurable lesion, no prior systemic therapy for advanced disease, and adequate organ function. Key exclusions include active autoimmune disease requiring immunosuppression, clinically meaningful effusions, hepatic encephalopathy, active infections or primary immunodeficiency, CNS metastases, significant bleeding risk or recent therapeutic anticoagulation/antiplatelet therapy, prior anti-CTLA-4 or anti-TIGIT therapy, and specific non-typical HCC histologies.

Design: Global, multicenter, Phase III, three-arm, randomized, open-label, sponsor-blinded study with an initial single-arm safety lead-in for the triplet (rilvegostomig + bevacizumab + tremelimumab) followed by a randomized comparison among the two experimental arms and the active comparator. Randomization occurs in the first-line advanced HCC setting.

Treatments: Arm A: tremelimumab + rilvegostomig + bevacizumab. Arm B: rilvegostomig + bevacizumab. Arm C: atezolizumab + bevacizumab (active comparator standard-of-care regimen in first-line advanced HCC). Rilvegostomig (AZD2936) is a bispecific humanized IgG1 antibody targeting PD-1 and TIGIT to enhance anti-tumor T-cell activity; its Fc domain is engineered to minimize effector functions. Early-phase data in heavily pretreated NSCLC demonstrated acceptable tolerability at an IV dose every 3 weeks, a recommended phase 2 dose of 750 mg, dose-proportional exposure with high peripheral PD-1/TIGIT receptor occupancy, and preliminary antitumor activity with partial responses and stable disease observed. Tremelimumab is an anti-CTLA-4 antibody; atezolizumab is an anti–PD-L1 antibody; bevacizumab is an anti–VEGF-A monoclonal antibody.

Outcomes: Primary: Overall survival for Arm A versus Arm C. Key secondary: Overall survival for Arm B versus Arm C; progression-free survival and objective response rate per RECIST 1.1 for Arms A and B versus Arm C; comparative OS, PFS, ORR, and duration of response between Arm A and Arm B; correlation of PD-L1 expression with OS, PFS, ORR, and DOR for Arms A and B versus Arm C; immunogenicity (anti-drug antibodies) for tremelimumab and rilvegostomig; and safety via AE/SAE monitoring per CTCAE v5.0. Follow-up for efficacy and safety is up to approximately 6 years.

Burden on patient: Moderate. As a Phase III immunotherapy/antiangiogenic trial, clinic visits for intravenous infusions (every 3 weeks typical for these agents) and regular safety labs will be required, along with imaging at standard intervals (approximately every 6–9 weeks early, then less frequently), similar to current standard-of-care schedules. Additional procedures include baseline and on-treatment tumor assessments, and blood draws for immunogenicity testing; pharmacokinetic-intense sampling is not indicated. No mandated additional biopsies are described beyond standard evaluations. Travel and time commitments align with other first-line ICI + bevacizumab regimens, with added visits during the safety lead-in for those enrolled in that phase.

Last updated: Oct 2025

Eligibility

Show Criteria

Inclusion Criteria:

* Locally advanced or metastatic and/or unresectable HCC

* WHO/ECOG performance status of 0 or 1

* BCLC stage B (that is not eligible for locoregional therapy) or stage C. Child-Pugh Score class A

* At least one measurable target lesion

* co-infected with HBV and HCV are not eligible

* Adequate organ and bone marrow function measured during the screening period

* Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC.

* Disease that is not amenable to curative surgical and/or locoregional therapies. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study.

Exclusion Criteria:

Medical condition

* Any evidence of uncontrolled intercurrent diseases

* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment

* History of another primary malignancy

* Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.

* Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention to maintain symptomatic control within 6 months prior to the first scheduled dose.

* History of active primary immunodeficiency or active infection

* History of hepatic encephalopathy

* Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol

* Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes is ineligible

Bleeding or other risks

HCC related

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

* Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)

* Prior treatment with anti-CTLA-4 and/or anti-TIGIT.

* Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment

Sites (161)

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Heidelberg, 3084, Australia

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Auchenflower, 4066, Australia

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Camperdown, 2050, Australia

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São Paulo, 04014-002, Brazil

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São Paulo, 05652-9000, Brazil

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Vitória, 29043-272, Brazil

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Porto Alegre, 91350-200, Brazil

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Santa Maria, 97015-450, Brazil

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Edmonton, Alberta, T6G 1Z2, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Shandong, China

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Wuhan, 430079, China

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Wenzhou, 325000, China

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Shenyang, 110042, China

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Luoyang, 471000, China

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Nanchang, 330029, China

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Nanjing, 210029, China

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Nanning, 530021, China

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Nantong, 226361, China

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Neijiang, 641100, China

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Shanghai, 201114, China

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Beijing, 100034, China

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Beijing, 100142, China

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Beijing, CN-100730, China

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Changchun, 130021, China

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Changsha, 410013, China

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Chengdu, 610041, China

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Chongqing, 400010, China

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Deyang, 618000, China

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Fuzhou, 350005, China

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Guangzhou, 510060, China

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Guangzhou, 510515, China

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Guiyang, 550002, China

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Harbin, 150081, China

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Hohhot, 010020, China

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Linyi, 276000, China

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Lishui, 323000, China

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Clichy, 92118, France

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Lille, 59000, France

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Lyon, 69317, France

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Nantes, 44093, France

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Nice, 06200, France

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Pessac, 33604, France

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Rennes, 35000, France

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Hamburg, 20246, Germany

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Aachen, 52074, Germany

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Berlin, 13353, Germany

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Dortmund, 44137, Germany

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Essen, 45122, Germany

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Frankfurt, 60590, Germany

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Göttingen, 37075, Germany

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Hanover, 30623, Germany

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Moers, 47441, Germany

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München, 81377, Germany

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Regensburg, 93053, Germany

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Ulm, 89081, Germany

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Shatin, 00000, Hong Kong

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Hong Kong, 999077, Hong Kong

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Delhi, 110029, India

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Hyderabad, 500032, India

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Mumbai, 400012, India

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Binnāguri, 734015, India

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Palermo, 90127, Italy

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Milan, 20162, Italy

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Rozzano, 20089, Italy

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Roma, 00168, Italy

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Milan, 20132, Italy

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Bologna, 40138, Italy

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Pisa, 56126, Italy

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Perugia, 06132, Italy

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Osakasayama-shi, 589-8511, Japan

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Yokohama, 241-8515, Japan

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Yokohama, 232-0024, Japan

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Tsu, 514-8507, Japan

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Toyoake-shi, 470-1192, Japan

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Tokyo, 104-0045, Japan

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Suita-shi, 565-0871, Japan

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Sendai, 981-0914, Japan

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Sapporo, 006-8555, Japan

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Morioka, 028-3695, Japan

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Musashino-shi, 180-8610, Japan

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Nagoya, 464-8681, Japan

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Okayama, 700-8558, Japan

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Osaka, 541-8567, Japan

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Saga, 849-8501, Japan

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Bunkyō City, 113-8655, Japan

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Chiba, 260-8677, Japan

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Fukuoka, 811-1395, Japan

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Hiroshima, 734-8530, Japan

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Hiroshima, 734-8551, Japan

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Iizuka-shi, 820-8505, Japan

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Kashiwa, 227-8577, Japan

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Kita-gun, 761-0793, Japan

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Kobe, 650-0017, Japan

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Kōtoku, 135-8550, Japan

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Kumamoto, 860-8556, Japan

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Kurume-shi, 830-0011, Japan

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Kyoto, 602-8566, Japan

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Matsuyama, 790-0024, Japan

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Mitaka-shi, 181-8611, Japan

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Madrid, 28007, Spain

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Madrid, 28027, Spain

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Madrid, 28040, Spain

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Santander, 39008, Spain

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Taoyuan District, 333, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 112, Taiwan

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Muang, 40002, Thailand

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Hat Yai, 90110, Thailand

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Dusit, 10300, Thailand

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Chiang Mai, 50200, Thailand

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Bangkok, 10700, Thailand

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Ubonratchathani, 34000, Thailand

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Bangkok, 10210, Thailand

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Izmir, 35100, Turkey (Türkiye)

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Istanbul, 34180, Turkey (Türkiye)

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Erzurum, 25240, Turkey (Türkiye)

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Ankara, 06530, Turkey (Türkiye)

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Altındağ, 06230, Turkey (Türkiye)

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Phoenix, Arizona, 85054, United States

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Palo Alto, California, 94304, United States

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New Haven, Connecticut, 06511, United States

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Newark, Delaware, 19713, United States

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Jacksonville, Florida, 32224, United States

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Atlanta, Georgia, 30322, United States

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Grand Rapids, Michigan, 49503, United States

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Rochester, Minnesota, 55905, United States

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New Brunswick, New Jersey, 08901, United States

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New York, New York, 10029, United States

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New York, New York, 10065, United States

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Cleveland, Ohio, 44195, United States

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Oklahoma City, Oklahoma, 73104, United States

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Arlington, Virginia, 22201, United States

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Milwaukee, Wisconsin, 53226, United States

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Ho Chi Minh City, 700000, Vietnam

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Hanoi, 100000, Vietnam

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A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Trial Details

Show Summary from Sponsor

More details:

Investigational Drug AI Analysis

Show for: Rilvegostomig (AZD2936)

Overview

Mechanism of action

Efficacy

Safety

Key trials (selection)

Further reading

HealthScout AI Analysis

Eligibility

Show Criteria

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