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Oncology Pipeline
At GSK, our pipeline is focused on unlocking the science of the immune system, human genetics, and advanced technologies to develop vaccines and specialty medicines.
Our products in development progress through three stages: phase I, phase II, and phase III/registrational. Each of these phases allows us to assess the safety and efficacy of our investigational products to eventually provide data to support applications for regulatory approval.
View our ongoing, innovative research with oncology diseases.
Phase 1 Overview
This is the first time a new vaccine or medicine is tested in humans; it will usually be given to a small group of healthy volunteers, or it may be tested on patients who have the condition it is designed to treat. The principal objectives in phase I are to ensure the new vaccine or medicine presents no major safety issues, and to see clear evidence that it can reach the targeted body area and remain there long enough to deliver its potential benefits. We also seek to gain preliminary evidence the vaccine or medicine can offer therapeutic value or help to prevent the disease in question.
DISEASE STATES
No studies exist in this phase
Belantamab mafodotin | Anti-BCMA antibody‑drug conjugate
DREAMM-5: platform study of belantamab mafodotin alone and in combination with GSK3174998 (OX40 agonist antibody), feladilimab (ICOS agonist IgG4 antibody), nirogacestat alone or in combination with Rd or Pd, dostarlimab (anti-PD-1 antibody), or isatuximab in patients with relapsed/refractory multiple myeloma
DREAMM-9: belantamab mafodotin in combination with bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for ASCT
DREAMM-11: a dose-escalation study of belantamab mafodotin in Japanese patients with relapsed/refractory multiple myeloma
DREAMM-12: a pharmacokinetics and safety study of belantamab mafodotin in patients with relapsed/refractory multiple myeloma who have normal or varying degrees of impaired renal function
DREAMM-13: a pharmacokinetics and safety study of belantamab mafodotin in patients with relapsed/refractory multiple myeloma who have normal or varying degrees of impaired hepatic function
DREAMM-20: study to investigate the safety and efficacy of GSK2875914 as monotherapy and in combination with other treatments in patients with multiple myeloma
OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer
OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer
No studies exist in this phase
GARNET~: dose-escalation and ‑expansion study in patients with advanced solid tumors
NCT04446351: first-time-in-human study of GSK6097608 as monotherapy and in combination with dostarlimab with or without belrestotug in advanced solid tumors
NCT03329001: a crossover bioavailability and bioequivalence study of niraparib tablet and capsule formulation in patients with advanced solid tumors
NCT05277051: first in-human study of GSK4381562 as monotherapy, in combination with dostarlimab, or in combination with dostarlimab and belrestotug in patients with advanced solid tumors
AMBER§: dose-escalation and -expansion study of cobolimab alone or in combination with other anticancer agents in patients with advanced solid tumors
Belrestotug | Anti-TIGIT IgG1 antibody¶
TIG-006¶: study of belrestotug in combination with standard of care or investigational therapy in advanced solid tumors
GSK4524101
NCT06077877: study to determine maximum tolerated dose of GSK4524101 as monotherapy and in combination with niraparib in patients with solid tumors
No studies exist in this phase
Phase 2 Overview
At this stage, the potential vaccine or medicine is usually tested to understand the effectiveness against the disease it is designed to treat and appropriate dosing levels. The performance of the medicine in one group of patients may be compared against another group of patients receiving a placebo (a treatment that looks the same as the potential new medicine but has no active ingredients) or an existing treatment.
DISEASE STATES
No studies exist in this phase
PERLA: dostarlimab with chemotherapy vs pembrolizumab with chemotherapy in metastatic nonsquamous NSCLC
Belrestotug | Anti-TIGIT IgG1 antibody¶
ENTRÉE-Lung: platform trial of novel regimens versus standard of care in NSCLC
NCT05565378: platform study utilizing a master protocol to evaluate novel immunotherapy combinations in patients with previously untreated, locally advanced unresectable or metastatic, PD-L1-selected non-small cell lung cancer
Pembrolizumab I Dostarlimab I Belrestotug I GSK6097608
GALAXIES-LUNG-201: platform study utilizing a master protocol to evaluate of novel immunotherapy combinations in patients with previously untreated, locally advanced unresectable/metastatic, PD-L1–selected NSCLC
Belantamab mafodotin | Anti-BCMA antibody‑drug conjugate
DREAMM-6: study to investigate alternative dosing regimens of belanatamab mafodotin in patients with relapsed/refractory multiple myeloma
DREAMM-14: study to investigate alternative dosing regimens of belantamab mafodotin in patients with relapsed/refractory multiple myeloma
DREAMM-5: platform study of belantamab mafodotin alone and in combination with GSK3174998 (OX40 agonist antibody), feladilimab (ICOS agonist IgG4 antibody), nirogacestat alone or in combination with Rd or Pd, dostarlimab (anti-PD-1 antibody), or isatuximab in patients with relapsed/refractory multiple myeloma
DREAMM-20: study to investigate the safety and efficacy of GSK2875914 as monotherapy and in combination with other treatments in patients with multiple myeloma
OVARIO: study of first-line maintenance therapy with niraparib and bevacizumab following response on front-line platinum-based chemotherapy and bevacizumab in patients with advanced ovarian cancer
Long-term treatment-extension study in patients who have completed a prior GSK-sponsored niraparib study
OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer
OPAL: study of treatment with niraparib in combination with dostarlimab and bevacizumab in patients with ovarian cancer
No studies exist in this phase
Long-term treatment-extension study in patients who have completed a prior GSK-sponsored niraparib study
PAVO£: niraparib as monotherapy in the treatment of patients with locally advanced or metastatic solid tumors with a PALB2 mutation
NCT04641247: a long-term treatment-extension study of niraparib in patients who have completed a prior GSK-sponsored niraparib study
Belrestotug | Anti-TIGIT IgG1 antibody¶
TIG-006¶: study of belrestotug in combination with standard of care or investigational therapy in advanced solid tumors
GSK4524101
NCT06077877: study to determine maximum tolerated dose of GSK4524101 as monotherapy and in combination with niraparib in patients with solid tumors
NCT0344113: extended access of momelotinib in patients with primary myelofibrosis or post-polycythemia vera/post-essentail thrombocythemia myelofibrosis
AZUR-1: dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Pembrolizumab I Dostarlimab I Belrestotug I GSK6097608
GALAXIES-LUNG-201: platform study utilizing a master protocol to evaluate of novel immunotherapy combinations in patients with previously untreated, locally advanced unresectable/metastatic, PD-L1–selected NSCLC
Dostarlimab I Belrestotug I GSK6097608
GALAXIES H&N-202: study evaluating novel immunotherapy combinations as first-line treatment of PD-L1-positive, recurrent/metastatic HNSCC
Phase 3 Overview
This phase consists of a much larger and potentially longer trial, often involving hundreds or possibly thousands of participants from a range of different countries. The principal objectives in phase III are to demonstrate the safety and effectiveness of the new vaccine or medicine in the typical patient likely to use it; confirm effective dosing levels; identify contraindications; build knowledge of the benefits of the vaccine or medicine and compare them with any risks; and compare results against any currently achieved by existing treatments. Regulators will determine how a new product should be used and which patients should qualify for it based on all the evidence from clinical and pre-clinical studies.
DISEASE STATES
No studies exist in this phase
RUBY: dostarlimab in combination with carboplatin-paclitaxel compared with placebo and carboplatin-paclitaxel in patients with primary advanced or first recurrent endometrial cancer
COSTAR Lung: cobolimab in combination with dostarlimab and docetaxel in advanced NSCLC that has progressed on prior anti-PD-(L)1 therapy and chemotherapy
ZEAL-1L: niraparib with pembrolizumab vs placebo with pembrolizumab as maintenance therapy in NSCLC
Cobolimab | Anti-TIM-3 antibody
COSTAR Lung: cobolimab in combination with dostarlimab and docetaxel in advanced NSCLC that has progressed on prior anti-PD-(L)1 therapy and chemotherapy
Belantamab mafodotin | Anti-BCMA antibody‑drug conjugate
DREAMM-7: belantamab mafodotin in combination with bortezomib and dexamethasone compared with daratumumab, bortezomib, and dexamethasone in patients with relapsed/refractory multiple myeloma
DREAMM-8: belantamab mafodotin in combination with pomalidomide and dexamethasone vs pomalidomide, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma
NCT04549363: Characterization of corneal epithelial changes in patients with relapsed/refractory multiple myeloma treated with belantamab mafodotin
FIRST†: study of niraparib alone or in combination with dostarlimab and/or bevacizumab as maintenance therapy following first-line treatment with platinum-based chemotherapy alone or in combination with dostarlimab and/or bevacizumab in newly diagnosed advanced ovarian cancer
FIRST†: study of niraparib alone or in combination with dostarlimab and/or bevacizumab as maintenance therapy following first-line treatment with platinum-based chemotherapy alone or in combination with dostarlimab and/or bevacizumab in newly diagnosed advanced ovarian cancer
AZUR-2: dostarlimab perioperative monotherapy in patients with untreated T4N0 or stage III dMMR/MSI-H resectable colon cancer
No studies exist in this phase
Disclaimer
This document contains information for healthcare providers and is intended solely for educational purposes. This display includes ongoing clinical trials for both approved and investigational compounds.
Some agents are approved in select indications. Inclusion in this display does not imply regulatory approval for these compounds or all indications. Information about all trials can be found at www.clinicaltrials.gov. All clinical study information updated as of October 5, 2023.
Footnotes
† In collaboration with ENGOT, the European Network of Gynaecological Oncological Trial groups.
‡Not yet enrolling.
¶Collaboration and license alliance between GSK and iTeos Therapeutics.
~This trial is no longer enrolling patients with endometrial cancer.
§This trial is only enrolling patients for Cohort 2E in NSCLC.
£ Collaboration between GSK and Tempus.
¥ Collaboration and license alliance between GSK and iTeos Therapeutics.
