After cancer surgery,
the next step is yours.
A clinical study is now enrolling adults who have had surgery to remove lung cancer, melanoma, or kidney cancer. The study compares HLX17 — an investigational anti-PD-1 antibody — to Keytruda® (pembrolizumab). Both groups receive an active drug. There is no placebo.
After surgery for cancer, one of the biggest concerns is preventing the cancer from coming back. Immunotherapy — medicine that helps the immune system find and respond to cancer cells — has shown meaningful results when given after surgery in certain cancers. This study compares an investigational anti-PD-1 antibody with an established one to build the evidence needed to make high-quality immunotherapy more accessible.
What is this study, and what does it involve?
This is a Phase I, randomized, double-blind clinical study. It compares HLX17 — an investigational anti-PD-1 antibody — to Keytruda® (pembrolizumab), an already-approved immunotherapy drug, in people who have had surgery to remove certain solid tumours.
PD-1 is a protein on immune cells that can act like a brake, letting cancer cells hide from the immune system. Anti-PD-1 antibodies block this brake, helping the immune system detect those cells. HLX17 is a biosimilar: designed to work in exactly the same way as Keytruda® — same mechanism, same safety standard, same effectiveness.
Randomized means participants are assigned by chance to one of two groups. Double-blind means neither you nor your study doctor will know which drug you receive during the initial treatment period. Both groups receive an active drug — there is no placebo.
The two groups do not follow an identical schedule. If you are assigned to HLX17, you continue on HLX17 for up to 12 months. If you are assigned to the Keytruda® group, you receive Keytruda® for about 6 months (8 treatment cycles), then switch to HLX17 for the remainder of the study period. Your study team will explain exactly what this means for you based on your group assignment.
No Placebo
Both arms receive an active anti-PD-1 antibody — HLX17 or Keytruda®.
Up to 12 Months
Treatment runs for up to 12 months from your first infusion.
Phase I Study
Rigorous scientific design comparing two anti-PD-1 antibodies.
~174 Participants
Assigned equally between both groups across multiple sites.
Comparator Group Switches
If assigned to Keytruda®, you switch to HLX17 after about 6 months of treatment.
Study quick facts
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No Placebo All participants receive an active drug
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Comparator Switches Keytruda® group moves to HLX17 after ~6 months
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HLX17 Investigational anti-PD-1 antibody
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Phase I Clinical research study
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Every 3 Weeks IV infusion schedule
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Multicenter Multiple sites, now enrolling
What participation means for you
Joining a clinical study is a personal decision. Here is what being part of this study can offer.
Access to an active anti-PD-1 antibody
Both groups receive treatment — either HLX17 or established Keytruda® — as adjuvant therapy following cancer surgery. No group receives a placebo.
Close monitoring throughout
Regular blood tests, physical exams, imaging scans, and heart assessments are built into the study schedule — giving you structured oversight during and after treatment.
Contributing to future patients
This study builds evidence that could make high-quality immunotherapy more accessible. Your participation helps future patients who need treatment like this.
Fully voluntary — always
You can choose to join or not join, and you can withdraw at any point. Your decision has absolutely no effect on your regular medical care.
What participation looks like
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01
Screening
Up to 28 daysThe study team reviews your medical history and runs eligibility tests. You sign the consent form before any tests begin.
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02
Treatment
Up to 12 monthsIV infusions every 3 weeks. Regular clinic visits include blood draws, physical exams, and imaging scans to monitor your health. If you are assigned to the Keytruda® group, you switch to HLX17 after about 6 months.
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03
Safety Follow-Up
30 & 90 days post-treatmentTwo check-ins after your last dose — one in-person, one by phone — to confirm you are well and record any ongoing effects.
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04
Survival Follow-Up
Every 12 weeks ongoingIf no disease has returned, you return to the site every 12 weeks for imaging to track long-term outcomes.
This study is open to…
The list below is an overview — not a substitute for a full review. The study team will go through your complete medical history before any decisions are made.
- You are aged 18 to 70
- Your BMI is between 18 and 30, and your weight is between 50 kg (110 lbs) and 85 kg (187 lbs)
- You are fully active and can carry out all normal daily activities without restriction (ECOG Performance Status 0)
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You had complete surgical removal of one of the following, with no evidence of remaining disease:
- Non-small cell lung cancer (NSCLC) — Stage IB (tumour ≥ 4 cm), Stage II, or Stage IIIA — and you received at least 1 cycle of platinum-based chemotherapy after surgery
- Cutaneous melanoma — Stage IIB, IIC, or Stage III (cutaneous only — not mucosal or ocular)
- Kidney cancer (renal cell carcinoma) — at intermediate-high or high risk of recurrence after kidney removal
- Your surgery was completed within the required timing window before study enrolment (the study team will confirm this)
- You have adequate blood counts and organ function (confirmed by blood tests at screening)
- You are willing to use effective contraception during the study and for at least 6 months after your last dose (if applicable)
- Are younger than 18 or older than 70
- Have previously received pembrolizumab (Keytruda®) or any other checkpoint inhibitor — including any PD-1, PD-L1, or CTLA-4 inhibitor
- Have a known active autoimmune disease requiring ongoing systemic treatment with steroids or immune-suppressing drugs
- Have known HIV infection, or active hepatitis B or hepatitis C
- Have a history of significant lung scarring, pulmonary fibrosis, or interstitial lung disease
- Have had a heart attack, poorly controlled heart rhythm problems, or significant heart failure in the past 6 months
- Have an active serious infection currently requiring treatment with antibiotics, antivirals, or antifungals
- Have had an organ or bone marrow transplant
- Have a separate active cancer diagnosed in the last 5 years (other than the one you had surgery for)
- Have cancer that has spread to the brain or spread to bone, or (for kidney cancer) have a residual blood clot in a major vessel after surgery
- Are currently taking corticosteroids or other immune-suppressing medication above a low replacement dose (some inhaled or topical steroid use is allowed — the study team will review your current medications)
- Have planned surgery scheduled during the study period (a needle biopsy or lymph node sampling procedure is still allowed)
- Have recently received a live vaccine, have a history of drug or alcohol misuse, or are taking part in another investigational product or device clinical study
- Are pregnant or breastfeeding
- Have significant nerve damage (peripheral neuropathy Grade 2 or above — causing meaningful weakness, numbness, or pain)
- Have a known severe allergy to pembrolizumab or any monoclonal antibody
- Have unstable thyroid problems (hyperthyroid or hypothyroid) at the time of screening
- Have any other health condition that, in the investigator's judgment, would make participation unsafe for you
Unsure whether you qualify? This overview covers the main criteria — the study team reviews your full medical history in detail before any decisions are made. Checking your eligibility online is the fastest way to get a personalised answer. It takes less than 2 minutes and puts you under no obligation whatsoever.
Your safety comes first
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Independent Safety Review Committee
An independent committee monitors participant safety throughout and has authority to pause or stop the study if concerns arise.
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Full written informed consent
You receive a detailed written explanation of the study — including all risks — before you are asked to make any decision. Take as much time as you need.
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Regular safety monitoring
Blood tests, physical exams, heart monitoring, and imaging are built into the schedule to catch any concerns early throughout your participation.
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Your right to withdraw — always
You can leave the study at any time, for any reason, with no effect on your standard medical care whatsoever.
Frequently asked questions
Who is this study open to?
Adults aged 18 to 70 who have had complete surgical removal of non-small cell lung cancer (Stage IB with tumour ≥ 4 cm, Stage II, or Stage IIIA — after receiving adjuvant platinum-based chemotherapy), cutaneous melanoma (Stage IIB, IIC, or Stage III), or kidney cancer (renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy). You must currently show no evidence of disease, be in good physical health, and meet specific criteria around prior treatment and timing since surgery. The eligibility section above gives a full overview.
Will I know which drug I am receiving?
No. This is a double-blind study — neither you nor your study doctor will know which drug you receive during the initial treatment period. You are randomly assigned to one of two groups: HLX17 or Keytruda® (pembrolizumab). Both are active anti-PD-1 antibodies. There is no placebo group in this study. If you are assigned to the Keytruda® group, you will switch to HLX17 after about 6 months of treatment — your study team will explain this in full if it applies to you.
How am I protected as a participant?
Your safety is overseen by an independent Safety Review Committee throughout the study. This committee monitors all participant data and can pause or stop the study if concerns arise. Before anything begins, you receive full written information about the study including all risks, and you have as much time as you need to decide. You can withdraw at any time without any impact on your regular care.
Are clinical trials safe?
All clinical studies carry potential risks. Anti-PD-1 antibodies like pembrolizumab have been studied extensively — their risk profile is well established. Known side effects include immune-related reactions (inflammation in the lungs, liver, skin, or other organs) and infusion-related reactions. The study team will explain every potential risk in full during the informed consent process. An independent committee also monitors safety throughout. You are never required to continue if you have concerns.
What does participation actually involve?
Participation involves IV infusions of study medication once every three weeks, plus regular clinic visits for blood tests, physical exams, imaging scans, and heart monitoring. The treatment period lasts up to 12 months from your first dose. After treatment ends, there are safety check-ins at 30 and 90 days after your last dose, then follow-up visits every 12 weeks. Your study team will walk you through the complete schedule — and answer every question — before you make any decision.
What is the difference between HLX17 and Keytruda®?
Keytruda® (pembrolizumab) is an approved anti-PD-1 immunotherapy drug with an established track record. HLX17 is a biosimilar — developed to be highly similar to Keytruda® in mechanism, safety, and effectiveness. The purpose of this study is to formally confirm they behave equivalently in the body (their pharmacokinetics). Biosimilars go through the same rigorous regulatory process as the original drug.
Why should I take part in a clinical study?
Both groups receive active treatment — either HLX17 or Keytruda® — as adjuvant immunotherapy after cancer surgery. You also receive structured monitoring throughout. Beyond your own care, data from this study may help make high-quality immunotherapy accessible to more patients in the future. That said, joining is entirely your choice — there is no pressure, and your care is not affected either way.
Can I leave the study if I change my mind?
Yes, always. Participation is completely voluntary. You can withdraw at any time, for any reason, with no consequence for your standard medical care.
Ready to find out if you qualify?
Checking your eligibility takes under 2 minutes, is completely free, and puts you under no obligation. If you may be a fit, a member of the study team will follow up to answer your questions and explain every next step.
Check Your Eligibility NowTakes under 2 minutes · Completely voluntary · No commitment