Olympia

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are conducting a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to compare HLX17 and US-sourced Keytruda in patients with resected non-small cell lung cancer, melanoma, or renal cell carcinoma. The study aims to evaluate how similar the pharmacokinetic profiles, efficacy, safety, and immune responses are between these two treatments in this patient population. Participants will receive either HLX17 or US-sourced Keytruda. Those in the HLX17 group will get 200 mg on Day 1 of every 3-week cycle for up to 12 months or until disease recurrence, death, new anti-tumor therapy, unacceptable toxicity, consent withdrawal, or study end. The Keytruda group will receive 200 mg every 3 weeks for 8 cycles 24 weeks, then switch to HLX17 on the same schedule until 12 months or similar conditions occur. During the study, participants will undergo various assessments including pharmacokinetic measurements such as drug concentration over time and at steady state, disease-free survival evaluation for up to 12 months, and monitoring for adverse events and laboratory abnormalities for up to 15 months. Safety follow-up includes vital signs, physical exams, ECGs, and immunogenicity evaluation. The total study duration includes treatment and safety monitoring phases.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating the effectiveness of amivantamab combined with either lazertinib or platinum-based chemotherapy in treating participants who have epidermal growth factor receptor mutated EGFRm non-small cell lung cancer NSCLC. This study focuses on advanced or metastatic NSCLC cases where standard curative treatments are not suitable. It aims to assess the antitumor activity of these treatment combinations in this patient population. Participants receive either amivantamab with oral lazertinib in 28-day cycles or amivantamab with intravenous chemotherapy consisting of carboplatin and pemetrexed in 21-day cycles. Treatment continues until disease progression, participant withdrawal, death, or investigator decision to stop treatment. The study is designed with two separate groups receiving these distinct treatment combinations. Throughout the study, participants will undergo assessments to monitor treatment effects and safety. Researchers will measure progression-free survival as the primary outcome up to 4 years and 6 months, along with secondary outcomes including dose adjustments, adverse events, overall survival, response rates, and duration of response. Participants are followed regularly during treatment to track these outcomes and manage any side effects until the studys completion.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the safety, tolerability, and dosing of nemtabrutinib combined with venetoclax compared to venetoclax plus rituximab in participants with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study aims to determine if the combination of nemtabrutinib and venetoclax improves progression-free survival based on established criteria assessed by blinded independent review. Participants in one group will take daily oral nemtabrutinib tablets starting from the first treatment cycle and begin venetoclax tablets from the second cycle, continuing up to two years or until disease progression or discontinuation. The other group will receive daily venetoclax tablets from the first cycle and intravenous rituximab infusions once per 28-day cycle for six cycles, also continuing up to two years or until disease progression or discontinuation. A treatment cycle lasts four weeks. Throughout the study, participants will undergo assessments of dose-limiting toxicities, adverse events, and treatment discontinuations due to side effects, with monitoring periods ranging from approximately 12 weeks to over five years depending on the outcome measured. Researchers will also evaluate progression-free survival, minimal residual disease, overall survival, response rates, and duration of response. Participants need to meet specific health criteria and will be monitored carefully during and after treatment to track safety and effectiveness measures.

Researchers are evaluating a drug called sigvotatug vedotin SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy, to assess its safety and effects in people with advanced solid tumors. This Phase 1 study aims to determine the side effects and whether sigvotatug vedotin works to treat various solid tumors including lung, head and neck, breast, esophageal, skin, pancreatic, bladder, cervical, gastric, and ovarian cancers. The study is divided into four parts to explore dosage, safety, and combination treatments. Participants may receive sigvotatug vedotin alone or combined with pembrolizumab, sometimes alongside chemotherapy drugs carboplatin or cisplatin, depending on the study part. Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to further test safety and effectiveness. Parts C and D study the drug combined with pembrolizumab and possibly chemotherapy in different tumor types and treatment settings, including people who have not previously received treatment. Treatments are given intravenously, with pembrolizumab administered every 3 or 6 weeks and chemotherapy every 3 weeks. During the study, participants undergo tumor biopsies, clinical evaluations, and monitoring for side effects, including blood tests and safety assessments. Researchers track adverse events, lab abnormalities, and dose-limiting toxicities up to 30-37 days after treatment, with some follow-up extending up to 3 years. They also measure tumor response using standard criteria and monitor survival and drug levels in the body. Participants will have regular visits for treatment and assessments throughout the study duration, which may last several years.

Researchers are evaluating the pharmacokinetic similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC compared to US-DARZALEX FASPRO in patients newly diagnosed with multiple myeloma MM who are not eligible for transplant. This phase 1 randomized, double-blind study aims to understand how these treatments perform when combined with lenalidomide and dexamethasone Rd in this patient group. The study is sponsored by Shanghai Henlius Biotech and focuses on transplant-ineligible MM patients with measurable disease and good performance status. Participants will receive either HLX15-SC or US-DARZALEX FASPRO via subcutaneous injections at a dose of 1800 mg weekly for the first 8 weeks Cycles 1-2 and every two weeks during Weeks 9-16 Cycles 3-4, with each cycle lasting 4 weeks. After completing 4 treatment cycles, based on clinical benefit and participant preference, patients may continue to receive the locally marketed daratumumab subcutaneous formulation combined with Rd for up to 32 weeks or until loss of benefit, death, unacceptable toxicity, withdrawal, or other protocol reasons. Following this period, participants will receive standard care according to local guidelines, which may include daratumumab. Throughout the study, participants will undergo evaluations including pharmacokinetic assessments at 7 days and 16 weeks, safety monitoring through adverse events, vital signs, physical exams, lab tests, and electrocardiograms, as well as immunogenicity and efficacy assessments such as overall response rate and time to response. The total treatment duration is up to 32 weeks, followed by continued standard care. These measures help researchers understand treatment effects, safety, and patient response over time.

Researchers are evaluating the effectiveness and safety of standard chemotherapy with or without the drug INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma PDAC with a KRAS G12D mutation and have not received prior treatment for metastatic disease. This phase 3 study compares two groups to understand whether adding INCB161734 to chemotherapy improves outcomes in this condition. Participants will receive either oral INCB161734 tablets combined with chemotherapy chosen by their doctor either mFOLFIRINOX or GemNabP or a placebo tablet combined with the same chemotherapy options. The treatments are given according to the study protocol, and the study is conducted in a randomized, double-blind design to fairly compare the effects of INCB161734 plus chemotherapy versus placebo plus chemotherapy. During the study, participants will be monitored for overall survival, progression-free survival, and tumor response up to about two to three years. Researchers will also assess treatment side effects, quality of life using questionnaires, and other health outcomes. Participants will have regular visits for assessments, and safety will be closely tracked throughout the study period, which lasts until the study completion date in 2029.