Advanced Malignant Solid NeoplasmPhase 1/2NCT03217747
Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies
A Phase 1/2 study testing Avelumab, Ivuxolimab and Radiation Therapy in people with Advanced Malignant Solid Neoplasm and Castration-Resistant Prostate Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I/II trial studies the side effects of avelumab when given in different combinations with utomilumab, anti-OX40 antibody PF-04518600, and radiation therapy in treating patients with malignancies that have spread to other places in the body (advanced). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Castration-Resistant Prostate Carcinoma, Malignant Solid Neoplasm
- What is being tested?
- Avelumab, Ivuxolimab and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2017to 30 Apr 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be refractory to, or intolerant of, established therapy known to provide clinical benefit for their conditions, or where subjects refuse existing therapies.
- Subjects must have measurable disease (RECIST v 1.1) or patients may have bone metastatic disease evaluable by Prostate Cancer Working Group 2 (PCWG2) for subjects with metastatic castration-resistant prostate cancer (CRPC) or according to tumor evaluation criteria best suitable and accepted for the tumor type evaluated.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Platelets >= 100 x 10^9/L (For patients with hepatocellular carcinoma, platelets >= 70 x 10^9/L).
- Hemoglobin >= 9 g/dL.
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L.
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- White blood cell (WBC) >= 3 x 10^9/L.
- Alanine transaminase (ALT) =< 2.5 x upper normal limit (ULN) (=< 5 x ULN for subjects with documented metastatic disease to the liver).
- Aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with documented metastatic disease to the liver).
- Alkaline phosphatase < 4 x ULN.
- Total bilirubin =< 1.5 x ULN (In the expansion cohort, subjects with Gilbert's syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x ULN).
- Albumin >= 3 g/dL.
- Serum creatinine =< 2 x upper limit of normal (ULN) or estimated creatinine clearance >= 30 ml/min as calculated using the Cockcroft-Gault formula.
- Subject has recovered to grade =< 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v 4.03) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia. The exceptions for such effects are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteria.
- Life expectancy of at least 12 weeks.
- Negative serum pregnancy test in women of childbearing potential within 7 days of first dose of treatment and patients of child-bearing potential must agree to use effective contraception during and after 90 days post dose. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable or mechanical contraception; women who are single and women whose male sexual partners have been vasectomized or whose male sexual partners have received or are utilizing mechanical contraceptive devices.
- Subjects must have biopsiable disease. For Arms A, B, and C, subjects must have at least two lesions amenable to biopsy and response evaluation. For Arm D subjects should have at least three lesions amenable to biopsy, response evaluation, and radiation. Tumor lesions used for biopsy should not be lesions used as RECIST target lesions. However, if patients in Arm D do not have three separate lesions, patients will be eligible if there are two lesions, in which one is > 2 centimeters (short axis) and can be used for both biopsy and response evaluation.
- Subjects must give informed consent according to the rules and regulations of the individual participating sites.
Who cannot join
- Subjects with primary central nervous system (CNS) tumor or CNS tumor involvement. However, subjects with metastatic CNS tumors may participate in this study if the subject is:
- > 4 weeks from prior therapy completion (including radiation and/or surgery)
- Clinically stable with respect to the CNS tumor at the time of study entry
- Not receiving steroid therapy in treating CNS tumor or CNS tumor involvement
- Not receiving anti-convulsive medications (that were started for brain metastases).
- Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of study drug administration (6 weeks for mitomycin C or nitrosoureas). Palliative radiotherapy to a limited field is allowed after consultation with the medical monitor at any time during study participation, including during screening, unless it's clearly indicative of disease progression.
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- Subjects with prior anti-PD-1, anti-PD-L1 treatment. For Arms A and D, subjects may not have had prior 4-1BB treatment. For Arm B, subjects may not have had prior OX40 treatment. For Arm C, subjects may not have had prior 4-1BB or OX40 treatment.
- Diagnosis or recurrence of invasive cancer other than the present cancer within 3 years (except basal or squamous cell carcinoma of the skin that has been definitively treated).
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association classification class II), or serious cardiac arrhythmia requiring medication.
- Active infection requiring systemic therapy.
- Treatment with an investigational anti-cancer study drug within 4 weeks prior to study drug administration date.
- Concurrent therapy with approved or investigational anticancer therapeutics.
- Known prior severe hypersensitivity to investigational product(s) or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 4.03 grade >= 3).
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent; c. steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication).
- Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
- Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid (RNA) if anti-HCV antibody screening test positive).
- Vaccination (live attenuated virus) within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
- Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigator's judgment are acceptable.
- Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Pregnancy or lactation.
- Men whose partner is a woman of child-bearing potential, (i.e. biologically able to conceive), and who is not employing two forms of highly effective contraception. Highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 90 days after the end of study treatment. Women of child-bearing potential is defined as sexually mature women who are not surgically sterile or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months).
- A diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
- Has had prior radiation therapy within the past 3 months where the high dose area of the prior radiation would overlap with the high dose area of the intended radiation based on the judgement of the treatment oncologist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study to Evaluate the Safety and Tolerability of Avelumab in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies
This phase I/II trial studies the side effects of avelumab when given in different combinations with utomilumab, anti-OX40 antibody PF-04518600, and radiation therapy in treating patients with malignancies that have spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as avelumab, utomilumab, and anti-OX40 antibody PF-04518600, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy rays to kill tumor cells and shrink tumors. It is not yet known how well avelumab works in combination with these other anti-cancer therapies in patients with advanced malignancies.
Read the detailed description
PRIMARY OBJECTIVES:
- For Arm D, to establish the safety, tolerability, and dose-limiting toxicities (DLTs) of different treatment combinations of avelumab when administered in combination with a checkpoint agonist with radiation in patients with metastatic solid tumors in order to estimate the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D).
II. To correlate pre- and post-treatment CD8 expression with clinical benefit (complete response [CR], partial response [PR], or stable disease [SD] for > 6 months).
SECONDARY OBJECTIVES:
- To evaluate the efficacy of the different treatment combinations in patients with metastatic solid tumors by assessing objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune-related RECIST (irRECIST).
II. To evaluate the efficacy of the different treatment combinations in patients with metastatic solid tumors by assessing progression-free survival (PFS), duration of response (DOR), and overall survival (OS).
EXPLORATORY OBJECTIVES:
- To understand the mechanism of action of the avelumab plus an immune modulator combination, as well as potential mechanisms of resistance.
II. To characterize the effect of avelumab combinations on immune biomarkers in peripheral blood and tumor tissue obtained from subjects pre- and post-treatment.
III. To compare the response in irradiated versus non-irradiated lesions in Arm D.
IV. To investigate immune biomarkers that are potentially predictive of response and resistance with the combination of avelumab and an immune modulator.
OUTLINE: Patients are assigned to 1 of 6 arms.
ARM A: Patients receive utomilumab intravenously (IV) over 60 minutes on day 1 of each cycle and avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive anti-OX40 agonist monoclonal antibody PF-04518600 IV over 60 minutes on days 1 and 15 of each cycle and avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM C: Patients receive anti-OX40 agonist monoclonal antibody PF-04518600 IV over 60 minutes on days 1 and 15 of each cycle, utomilumab over 60 minutes on day 1, and avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM D: Patients undergo radiation therapy on days -5 to -1. Patients receive avelumab IV over 60 minutes on days 1 and 15 of beginning day 15 of cycle 1 and utomilumab IV over 60 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM E: DISCONTINUED AS OF AMENDMENT 9 (02/11/2020) Patients undergo radiation therapy on days -14 to -1. Patients receive avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1 and anti-OX40 agonist monoclonal antibody PF-04518600 IV over 60 minutes on days 1 and 15, and. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM F: DISCONTINUED AS OF AMENDMENT 9 (02/11/2020) Patients undergo radiation therapy on days -14 to -1. Patients receive avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1, utomilumab IV over 60 minutes on day 1, and anti-OX40 agonist monoclonal antibody PF-04518600 IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients will be followed up at 30 days and then every 12 weeks.
- Conditions
- Advanced Malignant Solid Neoplasm, Castration-Resistant Prostate Carcinoma, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone
- Being tested
- Avelumab, Ivuxolimab, Radiation Therapy, Utomilumab
- Medical subject headings
- Neoplasm Metastasis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Also called Bavencio, MSB-0010718C, MSB0010718C
Given IV
IvuxolimabBiological
Also called Anti-OX40 Agonist Monoclonal Antibody PF-04518600, PF-04518600, PF-8600, PF04518600
Given IV
Radiation TherapyRadiation
Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated
Undergo radiation therapy
UtomilumabBiological
Also called PF 05082566, PF 5082566, PF-05082566, PF-2566
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A (utomilumab, avelumab) | Experimental | Patients receive utomilumab IV over 60 minutes on day 1 of each cycle and avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Avelumab; Biological: Utomilumab |
| Arm B (PF-04518600, avelumab) | Experimental | Patients receive anti-OX40 agonist monoclonal antibody PF-04518600 IV over 60 minutes on days 1 and 15 of each cycle and avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Avelumab; Biological: Ivuxolimab |
| Arm C (PF-04518600, utomilumab, avelumab) | Experimental | Patients receive anti-OX40 agonist monoclonal antibody PF-04518600 IV over 60 minutes on days 1 and 15 of each cycle, utomilumab over 60 minutes on day 1, and avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Avelumab; Biological: Ivuxolimab; Biological: Utomilumab |
| Arm D (avelumab, utomilumab, radiation therapy) | Experimental | Patients undergo radiation therapy on days -5 to -1. Patients receive avelumab IV over 60 minutes on days 1 and 15 of beginning day 15 of cycle 1 and utomilumab IV over 60 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Avelumab; Radiation: Radiation Therapy; Biological: Utomilumab |
| Arm E (avelumab, PF-04518600, radiation therapy) | Experimental | DISCONTINUED AS OF AMENDMENT 9 (02/11/2020) Patients undergo radiation therapy on days -14 to -1. Patients receive avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1 and anti-OX40 agonist monoclonal antibody PF-04518600 IV over 60 minutes on days 1 and 15, and. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Avelumab; Biological: Ivuxolimab; Radiation: Radiation Therapy |
| Arm F (avelumab, PF-04518600, radiation therapy) | Experimental | DISCONTINUED AS OF AMENDMENT 9 (02/11/2020) Patients undergo radiation therapy on days -14 to -1. Patients receive avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1, utomilumab IV over 60 minutes on day 1, and anti-OX40 agonist monoclonal antibody PF-04518600 IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Avelumab; Biological: Ivuxolimab; Radiation: Radiation Therapy; Biological: Utomilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicities (DLTs) (All Will be Graded According to CTCAEv4.03 Criteria)
DLTs were adverse events (AEs) related to study drug in the first 2 cycles and fulfilled one of the following
- Discontinuation due to drug and/or XRT-related toxicity before DLT period ends
- Delay >28 days in receiving the next cycle due to drug and/or XRT-related toxicity
- Hematologic
- Gr4 neutropenia ≥7 days
- Febrile neutropenia
- Gr ≥3 thrombocytopenia associated with bleeding, or Gr 4 thrombocytopenia
- Gr 4 anemia
- Non-hematologic
- Gr ≥3 nausea/vomiting or diarrhea ≥72 hours despite optimal supportive medications
- Gr ≥3 fatigue ≥7 days
- Gr≥2 pneumonitis ≥7 days despite corticosteroids
- Gr≥3 rash ≥7 days despite treatment
- Gr≥3 immune related toxicities ≥7 days despite corticosteroids
- Any other Gr≥3 non-hematological toxicity (except for asymptomatic electrolytes abnormalities or hair loss which is not dose-limiting)
- Gr≥3 AST, ALT, or total bilirubin elevation ≥7 days. Delay of treatment > 14 days due to non-hematologic toxicity
Measured: DLT was assessed during the first 2 cycles or 8 weeks (56 days) since C1D1 of treatment.
Secondary outcomes (6)
Objective Response Rate Per RECIST v1.1
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) using CT, MRI,or PET-CT scan: Complete Response (CR),Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Measured: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.
Objective Response Rate Per irRECIST
Per Immune-related Response Evaluation Criteria In Solid Tumors Criteria (irRECIST) using CT, MRI,or PET-CT scan: Immune-related Complete Response (irCR),Disappearance of all target lesions; Immune-related Partial Response (irPR), >=30% decrease in the sum of the longest diameter of target and new lesions; OR = irCR + irPR.
Measured: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.
Clinical Benefit Rate Per RECIST v1.1
Per RECIST v1.0 using CT, MRI,or PET-CT scan: CR,Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), Increase ≥20% of the sum of longest diameter compared with nadir (minimum 5 mm) or progression of non-target lesions or new lesion; Stable Disease (SD), Neither PR nor PD; Clinical benefit (CB) = CR + PR + SD ≥6 months.
Measured: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.
Clinical Benefit Rate Per irRECIST
Per irRECIST using CT, MRI,or PET-CT scan: irCR,Disappearance of all target lesions; irPR, >=30% decrease in the sum of the longest diameter of target and new lesions; Immune-related Progressive Disease (irPD), Increase ≥20% of the sum of longest diameter of target and new lesion compared with nadir (minimum 5 mm) or progression of non-target lesions ; Immune-related Stable Disease (irSD), Neither irPR nor irPD; Clinical benefit (CB) = irCR + irPR + irSD ≥6 months.
Measured: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.
Disease Control Rate Per RECIST v1.1
Per RECIST v1.0 using CT, MRI,or PET-CT scan: CR,Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; PD, Increase ≥20% of the sum of longest diameter compared with nadir (minimum 5 mm) or progression of non-target lesions or new lesion; SD, Neither PR nor PD; Disease control (DC) = CR + PR + SD.
Measured: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.
Disease Control Rate Per irRECIST
Per irRECIST using CT, MRI,or PET-CT scan: irCR,Disappearance of all target lesions; irPR, >=30% decrease in the sum of the longest diameter of target and new lesions; irPD, Increase ≥20% of the sum of longest diameter of target and new lesion compared with nadir (minimum 5 mm) or progression of non-target lesions ; irSD, Neither irPR nor irPD; Disease control (DC) = irCR + irPR + irSD.
Measured: At baseline and at 8-week intervals (± 7 days). Confirmatory scans were obtained 4-8 weeks following initial objective response. After 1 year of treatment scans at 12-week intervals (± 7 days), independent of cycle delays, assessed upto 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start2 Aug 2017
- Primary completion2 Sep 2025
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aung Naing, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217747
- Sponsor's protocol ID
- 2017-0014
- Other IDs
- NCI-2018-01118, 2017-0014
- Status last verified
- Oct 2026
- First submitted
- 12 Jul 2017
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lermi NO, Gouda MA, Ahmed J, Jiang X, Lee Y, Mohanty V, Derbala M, Stephen B, Jhingran A, Mohammad MM, Joo D, Francisco-Cruz A, Chen H, Calderon LA, Laberiano C, Arrechedera C, Pandurengan R, Gurses S, Yang Y, Solis Soto LM, Ahnert JR, Chen K, Meric-Bernstam F, Koay EJ, Javle M, Haymaker C, Naing A. Tumor microenvironment changes after treatment with avelumab and immune-stimulating agent combinations in patients with advanced solid tumors. Res Sq [Preprint]. 2026 Jan 19:rs.3.rs-7775526. doi: 10.21203/rs.3.rs-7775526/v1.
PubMed 41646361Ahmed J, Knisely A, Torrado C, Stephen B, Yang Y, Song J, Alshawa A, Zarifa A, Jhingran A, Koay EJ, Morris VK, Javle M, Wolff RA, Meric-Bernstam F, Pant S, Rodon J, Naing A. A phase I/II trial of avelumab combinations with ivuxolimab, utomilumab, and radiation therapy in patients with advanced gastrointestinal malignancies. Oncologist. 2025 Mar 10;30(3):oyaf032. doi: 10.1093/oncolo/oyaf032.
PubMed 40139261