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Renal Cell CarcinomaPhase 2ADAPTeRNCT02446860

A Study of Anti-PD1 (Nivolumab) Therapy as Pre- and Post-operative Therapy in Metastatic Renal Cell Cancer (ADAPTeR)

A Phase 2 study testing nivolumab in people with Renal Cell Carcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Single arm, open label, phase II trial. Participants to undergo biopsy of primary tumour followed by 8 weeks of nivolumab therapy followed by nephrectomy. Nivolumab to be continued post-operatively Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2015to Aug 2018
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically confirmed metastatic renal cell carcinoma of predominately clear cell type
  • At least one site of disease outside the kidney measurable per RECIST 1.1
  • Scheduled to undergo nephrectomy as part of treatment plan
  • No prior systemic therapy for renal cell carcinoma
  • Male or female, 18 years of age or older
  • Life expectancy of 12 weeks or greater
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  • ECOG performance status 0 or 1
  • Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (equivalent to 10 mg of prednisone daily or more) must be discontinued at least two weeks prior to administration of the study drug. Inhaled corticosteroids and adrenal replacement steroid doses of > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
  • Serum aspartate transaminase (AST) / serum alanine transaminase (ALT) ≤3x upper limit of normal (ULN)
  • Total serum bilirubin ≤1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin <3mg/dL (50µmol/L)
  • Serum creatinine ≤1.5 x ULN or creatinine clearance ≥40ml/min (measured or calculated using Cockcroft-Gault formula)
  • White blood cells (WBC) ≥ 2.0x109/L, Absolute neutrophil count (ANC) ≥1.5x109/L
  • Platelets ≥100 x109/L,
  • Haemoglobin ≥9.0 g/dL
  • Prothrombin time (PT) ≤1.5 x ULN
  • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Who cannot join

  • Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months.
  • Need for nephrectomy to relieve symptoms relating to the primary tumour or for emergency nephrectomy
  • History of severe hypersensitivity reaction to other monoclonal antibodies
  • Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
  • Known HIV or AIDS-related illness
  • Any active, known or suspected autoimmune disease or any condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and physiological replacement doses >10mg daily prednisolone equivalent are permitted in the absence of active autoimmune disease.
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  • Active infection requiring therapy
  • Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) indicating acute or chronic infection
  • Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy and for 26 weeks following the last dose of study drug. All female patients with childbearing potential must have a negative pregnancy test (serum or urine) prior to enrolment/nivolumab treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy and for 31 weeks after the last dose of study drug. Women who are not of childbearing potential and azoospermic men do not require contraception.
  • Current signs or symptoms of severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
  • Use of vaccines against infectious diseases (eg influenza, varicella) within 28 days of initiation of study therapy

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Royal Marsden NHS Foundation Trust

    London, SW36JJ

Other trials in United Kingdom

About this study

Single arm, open label, phase II trial. Participants to undergo biopsy of primary tumour followed by 8 weeks of nivolumab therapy followed by nephrectomy. Nivolumab to be continued post-operatively

Read the detailed description

Renal cell carcinoma (RCC) is diagnosed in around 8500 patients annually in the UK. Approximately one third of these patients present with metastatic disease where the RCC has spread to other organs. The mainstay of treatment for these patients is systemic drug therapy, but surgery to remove the primary kidney tumour (i.e. nephrectomy) may also provide clinical benefit.

There is no standard preoperative systemic drug therapy in metastatic RCC, but such preoperative therapy is used widely in the treatment of other cancer types. This approach has several potential advantages including shrinking the tumour to help improve surgical outcomes and to aid identification of appropriate postoperative Drug therapy.

Over the last 10 years several agents have demonstrated promising activity in RCC including the monoclonal antibody therapy nivolumab. This novel immunotherapy works by blocking an immune cell receptor (programmed death1(PD1)) which the cancer can otherwise utilise to evade an individuals immune system attack. This study will investigate the use of nivolumab therapy as a preoperative treatment in patients with metastatic RCC for whom nephrectomy is planned. A total of 19 patients will be recruited at the Royal Marsden Hospital Patients will be treated with nivolumab for 8 weeks prior to surgery, after which nivolumab therapy will restart and continue until such time that the patient is not receiving an overall clinical benefit.

The primary aim of the study will be to assess the safety of such a strategy, with further aims to assess clinical effectiveness. This is also a unique opportunity to further investigate the way in which nivolumab works and to identify predictors of treatment response. To achieve this patients will be asked to provide biopsy samples of their RCC pre \& post nivolumab treatment and their nephrectomy tissue for research use, alongside additional blood \& urine samples.

Being tested
nivolumab
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nivolumabDrug

    Also called Opdivo

    Nivolumab 3 mg/kg by intravenous infusion, given every two weeks for eight weeks prior to nephrectomy, then post-operatively until patient is no longer deriving clinical benefit.

Study groups in NCT02446860
Study groupRoleWhat they receive
NivolumabExperimentalNivolumab 3 mg/kg by intravenous infusion, given every two weeks for eight weeks prior to nephrectomy, then post-operatively until patient is no longer deriving clinical benefit
Receives: Drug: nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety profile of Nivolumab given pre- and post-nephrectomy in metastatic renal cell carcinoma. Safety will be assessed by a summary of adverse events and by the proportion of patients experiencing all grades of toxicity.

    Measured: Until disease progression, measured every 2 weeks, on average for 11 months

Secondary outcomes (1)

  1. Response rate

    Measured: Until progression or withdrawal of consent, measured every 8 weeks in first year and then every 12 weeks there after, on average for 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionAug 2018
  4. Study completionAug 2018

Why it stopped: The study was unable to recruit the target number of patients (enrolled 15 instead of 19) and did not extend recruitment.

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02446860
Sponsor's protocol ID
CCR 4151
Acronym
ADAPTeR
Status last verified
Jun 2025
First submitted
12 Mar 2015
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: The trial terminated early due to low recruitment and the small sample size 15 participants determined as insufficient for meaningful secondary analysis.

Publications

  • Au L, Hatipoglu E, Robert de Massy M, Litchfield K, Beattie G, Rowan A, Schnidrig D, Thompson R, Byrne F, Horswell S, Fotiadis N, Hazell S, Nicol D, Shepherd STC, Fendler A, Mason R, Del Rosario L, Edmonds K, Lingard K, Sarker S, Mangwende M, Carlyle E, Attig J, Joshi K, Uddin I, Becker PD, Sunderland MW, Akarca A, Puccio I, Yang WW, Lund T, Dhillon K, Vasquez MD, Ghorani E, Xu H, Spencer C, Lopez JI, Green A, Mahadeva U, Borg E, Mitchison M, Moore DA, Proctor I, Falzon M, Pickering L, Furness AJS, Reading JL, Salgado R, Marafioti T, Jamal-Hanjani M; PEACE Consortium; Kassiotis G, Chain B, Larkin J, Swanton C, Quezada SA, Turajlic S; TRACERx Renal Consortium. Determinants of anti-PD-1 response and resistance in clear cell renal cell carcinoma. Cancer Cell. 2021 Nov 8;39(11):1497-1518.e11. doi: 10.1016/j.ccell.2021.10.001. Epub 2021 Oct 28.

    PubMed 34715028

  • Re C, Ince WHJ, Bickley L, Blackmur JP, Ismail MH, Kyeremeh J, Kuusk T, Serrao EM, Jones JO, Stewart GD. Oligoprogressive renal cell carcinoma: What is the role of surgery? BJU Int. 2026 Aug;138(2):219-228. doi: 10.1111/bju.70281. Epub 2026 Apr 13.

    PubMed 41969229

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nivolumab in people with Renal Cell Carcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was unable to recruit the target number of patients (enrolled 15 instead of 19) and did not extend recruitment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety profile of Nivolumab given pre- and post-nephrectomy in metastatic renal cell carcinoma. Safety will be assessed by a summary of adverse events and by the proportion of patients experiencing all grades of toxicity. (time frame: Until disease progression, measured every 2 weeks, on average for 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446860, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.

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