Sponsor: AstraZeneca (industry)
Phase: 3
Start date: May 6, 2025
Planned enrollment: 1220
Rilvegostomig (AZD2936) is an investigational bispecific immune-checkpoint antibody being developed for solid tumors, most extensively studied in non-small-cell lung cancer (NSCLC). Clinical evidence remains preliminary and largely comes from the nonrandomized phase I/II ARTEMIDE-01 trial; randomized phase III NSCLC studies are ongoing. (pubmed.ncbi.nlm.nih.gov)
Rilvegostomig is a humanized IgG1 antibody that simultaneously targets PD-1 and TIGIT, inhibitory receptors found on T cells and natural killer cells. Dual blockade is intended to restore antitumor immune activity more effectively than inhibition of either pathway alone. Its Fc region contains three mutations designed to minimize Fc-mediated immune-effector activity. (ascopubs.org)
In checkpoint-inhibitor–experienced, PD-L1-positive advanced NSCLC, ARTEMIDE-01 established 750 mg intravenously every three weeks as the recommended phase II dose. Among patients treated at this dose, the objective response rate (ORR) was 5.6%, the six-month disease-control rate was 31.5%, and median progression-free survival (PFS) was 3.8 months. (pubmed.ncbi.nlm.nih.gov)
Updated results in 65 checkpoint-inhibitor–naïve patients receiving 750 mg every three weeks showed:
These single-arm results cannot establish whether rilvegostomig is superior to currently available checkpoint inhibitors. (annalsofoncology.org)
In 83 checkpoint-inhibitor–experienced patients, 54.2% experienced a treatment-related adverse event, including 8.4% with grade 3 events; no dose-limiting toxicities were observed, and 2.4% discontinued because of treatment-related toxicity. Immune-mediated adverse events occurred in 18.1%. (pubmed.ncbi.nlm.nih.gov)
Among the 65 checkpoint-inhibitor–naïve patients in the later analysis, grade 3 treatment-related adverse events occurred in 12.3%, treatment-related discontinuations in 3.1%, and no grade 4 or 5 treatment-related events were reported. (annalsofoncology.org)
Last updated: Sep 2026
Goal: Determine whether first-line rilvegostomig plus bevacizumab, with or without tremelimumab, improves outcomes compared with atezolizumab plus bevacizumab in advanced hepatocellular carcinoma (HCC). The primary comparison is overall survival with the three-drug regimen versus the control regimen.
Patients: Adults with unresectable, locally advanced or metastatic HCC not amenable to curative or locoregional therapy, BCLC stage B ineligible for locoregional therapy or stage C, Child-Pugh class A liver function, ECOG performance status 0–1, and measurable disease. Participants must not have received systemic therapy for intermediate or advanced HCC. Key exclusions include clinically significant uncontrolled illness, hepatic encephalopathy, CNS metastases, relevant bleeding or anticoagulation risks, and prior anti-CTLA-4 or anti-TIGIT treatment.
Design: Global, multicentre, randomised, open-label, sponsor-blinded, three-arm study. A single-arm safety lead-in of the three-drug regimen precedes the randomised period.
Treatments: Arm A receives rilvegostomig, bevacizumab, and tremelimumab; Arm B receives rilvegostomig and bevacizumab; Arm C receives atezolizumab and bevacizumab as the active comparator. Rilvegostomig is an investigational bispecific antibody that blocks PD-1 and TIGIT to enhance antitumour immune activity. Early single-arm NSCLC studies reported objective response rates of 29.0% in patients with PD-L1 TPS 1–49% and 61.8% in those with TPS ≥50% receiving 750 mg every three weeks; these findings do not establish efficacy in HCC or superiority to existing checkpoint inhibitors. Tremelimumab blocks CTLA-4, atezolizumab blocks PD-L1, and bevacizumab inhibits VEGF-mediated angiogenesis.
Outcomes: The primary endpoint is overall survival for Arm A versus Arm C. Secondary endpoints include overall survival for Arm B versus Arm C and Arm A versus Arm B; RECIST 1.1 progression-free survival, objective response rate, and duration of response; analyses by PD-L1 expression; antidrug antibodies; and adverse and serious adverse events graded by CTCAE v5.0. Outcomes are assessed for up to approximately six years.
Burden on patient: Moderate. Treatment requires clinic visits for combination therapy, along with repeated imaging, safety assessments, and blood tests over potentially prolonged follow-up. PD-L1 and antidrug-antibody assessments may require additional samples. The supplied information does not specify mandatory research biopsies, intensive pharmacokinetic sampling, or visit and scan frequency, so the incremental burden beyond routine advanced-HCC care cannot be estimated precisely.
Last updated: Sep 2026
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
São Paulo, 05652-9000, Brazil
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Porto Alegre, 91350-200, Brazil
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Toronto, Ontario, M5G 1X6, Canada
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Deyang, 618000, China
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Guangzhou, 510515, China
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Lishui, 323000, China
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Shanghai, 201114, China
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Wenzhou, 325000, China
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Status: Recruiting
Shatin, 00000, Hong Kong
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Status: Recruiting
Hong Kong, 999077, Hong Kong
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Status: Recruiting
Yokohama, 241-8515, Japan
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Status: Recruiting
Musashino-shi, 180-8610, Japan
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Status: Recruiting
Chiba, 260-8677, Japan
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Status: Recruiting
Kashiwa, 227-8577, Japan
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Status: Recruiting
Osakasayama-shi, 589-8511, Japan
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Status: Recruiting
Tokyo, 104-0045, Japan
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Status: Recruiting
Kyoto, 602-8566, Japan
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Status: Recruiting
Morioka, 028-3695, Japan
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Status: Recruiting
Taipei, 10002, Taiwan
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Status: Recruiting
Taipei, 112, Taiwan
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Status: Recruiting
Taoyuan District, 333, Taiwan
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Status: Recruiting
Palo Alto, California, 94304, United States
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Status: Recruiting
Grand Rapids, Michigan, 49503, United States
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Status: Recruiting
New Brunswick, New Jersey, 08901, United States
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Status: Recruiting
Auchenflower, 4066, Australia
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Status: Not yet recruiting
Heidelberg, 3084, Australia
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Status: Not yet recruiting
Camperdown, 2050, Australia
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Status: Not yet recruiting
Santa Maria, 97015-450, Brazil
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Status: Not yet recruiting
São Paulo, 04014-002, Brazil
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Status: Not yet recruiting
Vitória, 29043-272, Brazil
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Status: Not yet recruiting
Edmonton, Alberta, T6G 1Z2, Canada
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Status: Not yet recruiting
Halifax, Nova Scotia, B3H 1V7, Canada
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Status: Not yet recruiting
Cambridge, Ontario, N1R 3G2, Canada
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Status: Not yet recruiting
Brampton, Ontario, L6R 3J7, Canada
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Status: Not yet recruiting
Barrie, Ontario, L4M 6M2, Canada
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Status: Not yet recruiting
Québec, Quebec, G1J 1Z4, Canada
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Status: Not yet recruiting
Montreal, Quebec, H2X 0A9, Canada
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Status: Not yet recruiting
Linyi, 276000, China
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Status: Not yet recruiting
Beijing, 100034, China
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Status: Not yet recruiting
Beijing, 100142, China
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Status: Not yet recruiting
Beijing, CN-100730, China
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Status: Not yet recruiting
Changchun, 130021, China
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Status: Not yet recruiting
Changsha, 410013, China
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Status: Not yet recruiting
Chengdu, 610041, China
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Status: Not yet recruiting
Chifeng, 024000, China
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Status: Not yet recruiting
Chongqing, 400010, China
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Status: Not yet recruiting
Fuzhou, 350005, China
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Status: Not yet recruiting
Guangzhou, 510060, China
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Status: Not yet recruiting
Guiyang, 550002, China
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Status: Not yet recruiting
Harbin, 150081, China
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Status: Not yet recruiting
Hefei, 230022, China
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Status: Not yet recruiting
Hohhot, 010020, China
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Status: Not yet recruiting
Kunming, 650118, China
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Status: Not yet recruiting
Luoyang, 471000, China
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Status: Not yet recruiting
Nanchang, 330008, China
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Status: Not yet recruiting
Nanchang, 330029, China
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Status: Not yet recruiting
Nanjing, 210029, China
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Status: Not yet recruiting
Nanning, 530021, China
No email / No phone
Status: Not yet recruiting
Nantong, 226361, China
No email / No phone
Status: Not yet recruiting
Neijiang, 641100, China
No email / No phone
Status: Not yet recruiting
Shandong, China
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Status: Not yet recruiting
Shenyang, 110004, China
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Status: Not yet recruiting
Shenyang, 110042, China
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Status: Not yet recruiting
Weifang, 261000, China
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Status: Not yet recruiting
Wuhan, 430079, China
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Status: Not yet recruiting
Xi'an, 710100, China
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Status: Not yet recruiting
Zhengzhou, 450008, China
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Status: Not yet recruiting
Lille, 59000, France
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Status: Not yet recruiting
Lyon, 69317, France
No email / No phone
Status: Not yet recruiting
Pessac, 33604, France
No email / No phone
Status: Not yet recruiting
Toulouse, 31059, France
No email / No phone
Status: Not yet recruiting
Rennes, 35000, France
No email / No phone
Status: Not yet recruiting
Nantes, 44093, France
No email / No phone
Status: Not yet recruiting
Nice, 06200, France
No email / No phone
Status: Not yet recruiting
Clichy, 92118, France
No email / No phone
Status: Not yet recruiting
Frankfurt, 60590, Germany
No email / No phone
Status: Not yet recruiting
Essen, 45122, Germany
No email / No phone
Status: Not yet recruiting
Dresden, 01307, Germany
No email / No phone
Status: Not yet recruiting
Dortmund, 44137, Germany
No email / No phone
Status: Not yet recruiting
Bonn, 53127, Germany
No email / No phone
Status: Not yet recruiting
Berlin, 13353, Germany
No email / No phone
Status: Not yet recruiting
Aachen, 52074, Germany
No email / No phone
Status: Not yet recruiting
Lübeck, 23538, Germany
No email / No phone
Status: Not yet recruiting
Magdeburg, 39120, Germany
No email / No phone
Status: Not yet recruiting
Moers, 47441, Germany
No email / No phone
Status: Not yet recruiting
München, 81377, Germany
No email / No phone
Status: Not yet recruiting
Ulm, 89081, Germany
No email / No phone
Status: Not yet recruiting
Leipzig, 4103, Germany
No email / No phone
Status: Not yet recruiting
Hanover, 30623, Germany
No email / No phone
Status: Not yet recruiting
Hamburg, 20246, Germany
No email / No phone
Status: Not yet recruiting
Göttingen, 37075, Germany
No email / No phone
Status: Not yet recruiting
Frankfurt, 60488, Germany
No email / No phone
Status: Not yet recruiting
Bangalore, 560027, India
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Status: Not yet recruiting
Binnāguri, 734015, India
No email / No phone
Status: Not yet recruiting
Dehradun, 248016, India
No email / No phone
Status: Not yet recruiting
Delhi, 110029, India
No email / No phone
Status: Not yet recruiting
Hyderabad, 500032, India
No email / No phone
Status: Not yet recruiting
Mumbai, 400012, India
No email / No phone
Status: Not yet recruiting
Nashik, 422011, India
No email / No phone
Status: Not yet recruiting
Ahmedabad, 380058, India
No email / No phone
Status: Not yet recruiting
Vadodara, 391760, India
No email / No phone
Status: Not yet recruiting
Roma, 00168, Italy
No email / No phone
Status: Not yet recruiting
Bologna, 40138, Italy
No email / No phone
Status: Not yet recruiting
Milan, 20132, Italy
No email / No phone
Status: Not yet recruiting
Milan, 20162, Italy
No email / No phone
Status: Not yet recruiting
Palermo, 90127, Italy
No email / No phone
Status: Not yet recruiting
Perugia, 06132, Italy
No email / No phone
Status: Not yet recruiting
Pisa, 56126, Italy
No email / No phone
Status: Not yet recruiting
Rozzano, 20089, Italy
No email / No phone
Status: Not yet recruiting
Suita-shi, 565-0871, Japan
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Status: Not yet recruiting
Toyoake-shi, 470-1192, Japan
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Status: Not yet recruiting
Tsu, 514-8507, Japan
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Status: Not yet recruiting
Yokohama, 232-0024, Japan
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Status: Not yet recruiting
Nagoya, 464-8681, Japan
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Status: Not yet recruiting
Bunkyō City, 113-8655, Japan
No email / No phone
Status: Not yet recruiting
Fukuoka, 811-1395, Japan
No email / No phone
Status: Not yet recruiting
Hiroshima, 734-8530, Japan
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Status: Not yet recruiting
Hiroshima, 734-8551, Japan
No email / No phone
Status: Not yet recruiting
Iizuka-shi, 820-8505, Japan
No email / No phone
Status: Not yet recruiting
Kita-gun, 761-0793, Japan
No email / No phone
Status: Not yet recruiting
Kobe, 650-0017, Japan
No email / No phone
Status: Not yet recruiting
Kōtoku, 135-8550, Japan
No email / No phone
Status: Not yet recruiting
Okayama, 700-8558, Japan
No email / No phone
Status: Not yet recruiting
Osaka, 541-8567, Japan
No email / No phone
Status: Not yet recruiting
Saga, 849-8501, Japan
No email / No phone
Status: Not yet recruiting
Sapporo, 006-8555, Japan
No email / No phone
Status: Not yet recruiting
Sendai, 981-0914, Japan
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Status: Not yet recruiting
Kumamoto, 860-8556, Japan
No email / No phone
Status: Not yet recruiting
Kurume-shi, 830-0011, Japan
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Status: Not yet recruiting
Matsuyama, 790-0024, Japan
No email / No phone
Status: Not yet recruiting
Mitaka-shi, 181-8611, Japan
No email / No phone
Status: Not yet recruiting
Amsterdam, 1081HV, Netherlands
No email / No phone
Status: Not yet recruiting
Groningen, 9700 RB, Netherlands
No email / No phone
Status: Not yet recruiting
Maastricht, 6229 HX, Netherlands
No email / No phone
Status: Not yet recruiting
Rotterdam, 3015 GD, Netherlands
No email / No phone
Status: Not yet recruiting
Utrecht, 3584 CX, Netherlands
No email / No phone
Status: Not yet recruiting
Busan, 48108, South Korea
No email / No phone
Status: Not yet recruiting
Goyang-si, 410-769, South Korea
No email / No phone
Status: Not yet recruiting
Gyeonggi-do, 13620, South Korea
No email / No phone
Status: Not yet recruiting
Seongnam-si, 463-712, South Korea
No email / No phone
Status: Not yet recruiting
Seoul, 03080, South Korea
No email / No phone
Status: Not yet recruiting
Seoul, 03722, South Korea
No email / No phone
Status: Not yet recruiting
Seoul, 06351, South Korea
No email / No phone
Status: Not yet recruiting
Seoul, 5505, South Korea
No email / No phone
Status: Not yet recruiting
Barcelona, 08035, Spain
No email / No phone
Status: Not yet recruiting
Barcelona, 08036, Spain
No email / No phone
Status: Not yet recruiting
Madrid, 28007, Spain
No email / No phone
Status: Not yet recruiting
Madrid, 28027, Spain
No email / No phone
Status: Not yet recruiting
Madrid, 28040, Spain
No email / No phone
Status: Not yet recruiting
Santander, 39008, Spain
No email / No phone
Status: Not yet recruiting
Changhua, 500, Taiwan
No email / No phone
Status: Not yet recruiting
Kaohsiung City, 83301, Taiwan
No email / No phone
Status: Not yet recruiting
Taichung, 40447, Taiwan
No email / No phone
Status: Not yet recruiting
Tainan, 70403, Taiwan
No email / No phone
Status: Not yet recruiting
Tainan County, 71044, Taiwan
No email / No phone
Status: Not yet recruiting
Chiang Mai, 50200, Thailand
No email / No phone
Status: Not yet recruiting
Ubonratchathani, 34000, Thailand
No email / No phone
Status: Not yet recruiting
Muang, 40002, Thailand
No email / No phone
Status: Not yet recruiting
Hat Yai, 90110, Thailand
No email / No phone
Status: Not yet recruiting
Dusit, 10300, Thailand
No email / No phone
Status: Not yet recruiting
Bangkok, 10210, Thailand
No email / No phone
Status: Not yet recruiting
Bangkok, 10700, Thailand
No email / No phone
Status: Not yet recruiting
Izmir, 35100, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Altındağ, 06230, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Ankara, 06530, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Erzurum, 25240, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Istanbul, 34180, Turkey (Türkiye)
No email / No phone
Status: Not yet recruiting
Manchester, M20 4BX, United Kingdom
No email / No phone
Status: Not yet recruiting
London, W12 0HS, United Kingdom
No email / No phone
Status: Not yet recruiting
London, NW3 2QG, United Kingdom
No email / No phone
Status: Not yet recruiting
Cambridge, CB2 0QQ, United Kingdom
No email / No phone
Status: Not yet recruiting
Phoenix, Arizona, 85054, United States
No email / No phone
Status: Not yet recruiting
Tucson, Arizona, 85724, United States
No email / No phone
Status: Not yet recruiting
Santa Monica, California, 90404, United States
No email / No phone
Status: Not yet recruiting
New Haven, Connecticut, 06511, United States
No email / No phone
Status: Not yet recruiting
Newark, Delaware, 19713, United States
No email / No phone
Status: Not yet recruiting
Jacksonville, Florida, 32224, United States
No email / No phone
Status: Not yet recruiting
Fayetteville, Georgia, 30214, United States
No email / No phone
Status: Not yet recruiting
Chicago, Illinois, 60637, United States
No email / No phone
Status: Not yet recruiting
Shreveport, Louisiana, 71103, United States
No email / No phone
Status: Not yet recruiting
Detroit, Michigan, 48202, United States
No email / No phone
Status: Not yet recruiting
Rochester, Minnesota, 55905, United States
No email / No phone
Status: Not yet recruiting
New York, New York, 10032, United States
No email / No phone
Status: Not yet recruiting
New York, New York, 10029, United States
No email / No phone
Status: Not yet recruiting
New York, New York, 10065, United States
No email / No phone
Status: Not yet recruiting
Philadelphia, Pennsylvania, 19107, United States
No email / No phone
Status: Not yet recruiting
Pittsburgh, Pennsylvania, 15237, United States
No email / No phone
Status: Not yet recruiting
Houston, Texas, 77058, United States
No email / No phone
Status: Not yet recruiting
El Paso, Texas, 79902, United States
No email / No phone
Status: Not yet recruiting
Austin, Texas, 78705, United States
No email / No phone
Status: Not yet recruiting
Tyler, Texas, 75702, United States
No email / No phone
Status: Not yet recruiting
San Antonio, Texas, 78240, United States
No email / No phone
Status: Not yet recruiting
Fairfax, Virginia, 22031, United States
No email / No phone
Status: Not yet recruiting
Blacksburg, Virginia, 24060, United States
No email / No phone
Status: Not yet recruiting
Seattle, Washington, 98109, United States
No email / No phone
Status: Not yet recruiting
Milwaukee, Wisconsin, 53226, United States
No email / No phone
Status: Not yet recruiting
Hanoi, 100000, Vietnam
No email / No phone
Status: Not yet recruiting
Ho Chi Minh City, 700000, Vietnam
No email / No phone
Status: Not yet recruiting
Ottawa, Ontario, K1H 8L6, Canada
No email / No phone
Status: Withdrawn
Regensburg, 93053, Germany
No email / No phone
Status: Withdrawn
Atlanta, Georgia, 30322, United States
No email / No phone
Status: Withdrawn
Cleveland, Ohio, 44195, United States
No email / No phone
Status: Withdrawn
Oklahoma City, Oklahoma, 73104, United States
No email / No phone
Status: Withdrawn
Dallas, Texas, 75390, United States
No email / No phone
Status: Withdrawn